199 Trackwise Jobs - Page 6

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission. Responsibilities: Major responsibilities are as mentioned below but not limited to, Review and approval of technical documents of GPRD which includes analytical and formulation documents. Perform tool based investigations for CMO, R&D, plant, and contract labs to ensure compliance with cGxP regulations and guidelines. Review and approve QMS documents such as change controls, investigations, and audit reports in TrackWise. Handle market complaints and manage the quality management system (change control, CAPA, deviations, OOS, etc.). Coordinate with external/internal auditors and ensure timely closure of audit findings. Provide expert advice on cGxP regulations and guidelines. Prepare, review, and implement SOPs. Carry out internal quality audits of R&D lab and maintain Good Laboratory practices. Review and approval of risk assessments for commercial product support. Risk management, human factor, accelerated aging study, pFMEA, distribution study, sterilization assurance, etc. documents review. Monitor and evaluate the performance of process and analytical methods to identify any issues or deviations. Collaborate with other departments to ensure that all methods and procedures are compendial compliant. Represent subject matter expertise in the areas of process and Analytical (Validation, Verification, and Transfer) as a Quality SME internally and externally as needed. Compliance verification through GEMBA walks. Handling of SNC’s (Supplier Notification of change). Review and approval of Packaging development documents and data along with procedures. Review and approval of registration and commercial stability data along with trend analysis. Requirements: Master or Bachelor's degree in Life Sciences, Pharmaceutical Sciences, or a related field. At least 8-15 years of experience in Quality Assurance or related field. In-depth knowledge and understanding of cGxP regulations and guidelines. Excellent communication and interpersonal skills. Strong technical knowledge, investigational and problem-solving skills. Ability to work in a team environment. Proficient in Microsoft Office and other quality management systems. Proficiency in Microsoft Office and TrackWise8. Continual system improvement and cGxP mindset Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice. Show more Show less

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Show more Show less

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Show more Show less

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –LIMS Consultant - Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in LIMS Implementations & Configurations for Life Sciences industries to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Work closely with business stakeholders, laboratory personnel, and IT teams to gather and document LIMS requirements. Gather and analyse business requirements related to LIMS functionality and enhancements. Analyse laboratory workflows and processes to recommend and implement LIMS solutions. Translate business needs into functional specifications and system configurations. Configure, test, and validate LIMS functionalities to meet business needs. Conduct impact analysis and risk assessments for LIMS changes and enhancements. Serve as a liaison between business users and technical teams to ensure effective communication and system alignment. Participate in business process mapping and workflow optimization to enhance LIMS utilization. Provide input on LIMS enhancements and new feature development to improve system performance. Assist in troubleshooting, identifying, and resolving LIMS-related issues. Conduct user training sessions and provide end-user support. Work with laboratory teams to ensure LIMS supports laboratory practices, procedures, and workflows effectively. Identify opportunities for automation and process improvement within laboratory operations using LIMS. Master Data Design Configuration Analyse the Technical documents such as SOP/STP/Monograms/Pharmacopeial references and convert them into LIMS compatible data sets. Configure master data elements such as test methods, sample types, specifications, workflows, and stability studies within LIMS. Maintain data integrity, consistency, and version control across the system. Implement changes and updates to LIMS master data in alignment with business and regulatory needs. Collaborate with cross-functional teams to ensure accurate data migration and system integration. Troubleshoot and resolve issues related to master data configuration and system functionality. Work on optimizing data structures and database management within LIMS. Configurations & Customizations Develop, customize, and implement LIMS applications to meet laboratory and business requirements. Configure, extend, and support LabWare LIMS, LabVantage LIMS, and other LIMS platforms. Integrate LIMS with other enterprise systems such as ERP, ELN, CDS, MES, and laboratory instrumentation software. Design and optimize databases for efficient storage and retrieval of laboratory data. Develop and maintain system interfaces, workflows, and automation scripts to streamline laboratory processes. Provide technical support, troubleshooting, and bug fixes for LIMS applications, ensuring minimal downtime. Collaborate with laboratory personnel, IT teams, and stakeholders to enhance system functionality and usability. Create and maintain system documentation, including user guides, SOPs, validation protocols, and technical specifications. Ensure compliance with industry standards such as CGxP, PICS, FDA 21 CFR Part 11, EU GMP Annex 11 etc. Stay up to date with new LIMS technologies, trends, and best practices. Ensure system security, access control, and compliance with IT policies. Provide ongoing support and maintenance for LIMS applications. Engage in change management processes and drive adoption of new system functionalities. Work with vendors and third-party providers to Configure, implement upgrades and enhancements. Demonstrate teamwork by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Strong understanding of laboratory workflows, sample lifecycle management, and data integrity principles. Familiarity with analytical techniques, laboratory instrumentation, and regulatory standards. Exposure to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and ISO 17025 compliance. Experience in working with scientific and analytical teams to align LIMS functionality with laboratory operations. Understanding of quality control, stability studies, environmental monitoring, and batch release processes within laboratories. Proficiency in LIMS software (e.g., LabWare, LabVantage, STARLIMS, SampleManager, or similar platforms). Knowledge of system integration with ERP, MES, or other enterprise applications. Previous experience as a Business Analyst or System Administrator or Master Data Manager working with LIMS. Hands-on experience in master data configuration within LIMS platforms. Experience in system validation, testing, and documentation. Exposure to Enterprise IT applications like ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, etc. in Pharmaceutical organization Understanding of relational databases and SQL queries. Experience with scripting or automation tools for LIMS is a plus. Understanding of API integrations, web services, and middleware solutions for LIMS. Ability to troubleshoot system and data issues efficiently. Strong problem-solving and analytical skills. Excellent communication and stakeholder management abilities. Ability to work independently and as part of a cross-functional team. Strong attention to detail and commitment to data integrity. Adaptability to dynamic business and regulatory environments. Demonstrated track record in project management, governance, and reporting Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management. Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Comp. Science/ Life Sciences/Chemistry/Information Technology or a related field)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 4-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies or Leading Life sciences / Pharmaceutical Industries. Good interpersonal skills; Good written, oral and presentation skills Ideally, you’ll also have Information Security (ISO 27001) or Risk Management certifications LIMS admin certification or Equivalent Certified Scrum Master (CSM) or Equivalent (Preferred but not required). What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Show more Show less

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Show more Show less

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Show more Show less

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Show more Show less

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Show more Show less

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Show more Show less

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. The purpose of the Senior Associate/Lead, IT Systems Business Quality Assurance (BQA) role is to support the development and implementation of quality systems strategy and activities to support the Data and Analytics and Global statistical science organizations goals and objectives for IT systems. In support of this mission, the purpose of the role of BQA is to act as a quality consultant and leader in integrating the quality requirements into the business processes. The BQA will implement the quality plan and ensure consistency between the global requirements and local requirements. This includes the implementation of quality systems and assuring that these systems are aligned with appropriate quality and regulatory requirements. The BQA will act as a contact person regarding quality and business process compliance concerns with IT Systems in the clinical data flow. Primary Responsibilities Ensure local implementation of the Safety and Efficacy Quality System (SEQS) Review regional and/or local SOPs versus global policies. Review quality system documents and provides feedback. Recommend new procedures or changes to existing procedures where applicable. Provide quality oversight for compliance to SEQS. Escalate compliance issues to management locally and globally as appropriate. Ensure inspection readiness and compliance to global, regional, and/or local regulations Assist in interpreting relevant pharmacovigilance regulations and guidelines and acts as a contact person in the regional center and/or affiliates. Perform quality self-assessments. Facilitate audits and inspections. Coordinate audit responses including Trackwise system documentation. Communicate and ensure inspection readiness requirements are in place; e.g. organization and availability of documents such as training records, job description, backroom and/or front room organization, etc. Ensure the implementation and maintenance of regional and/or affiliate Quality Plan(s) Document the regional and/or affiliate quality systems requirements ensuring clear accountabilities. Manage the regional and/or affiliate quality plan(s). Provide updates to quality and business owners. Implement and manage Quality Systems Provide consultation on the integration of quality into business processes. Support the business on the application and facilitation of quality systems (deviations, notification to management, change control). Consult on root cause analysis for deviations. Drive trending of metrics to improve processes and compliance Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions. Monitor completion of deviations, CAPA related to deviations and change controls. Monitor completion of audit responses through metrics. Provide updates to management. Share key learning to drive simplification and replicate best practices in the region and globally. Coordinate quality improvement initiatives. Seek and implement simplification and process improvement. Information Technology Quality Support responsibilities Review, and approve as appropriate, documents associated with the development and maintenance of IT systems. Perform all responsibilities of IT Business Quality as defined in Computer System Policies and Procedures. Participate as a member of the IT Change Control Board as applicable. Coordinate interfaces with other related systems. Other Responsibilities Understand the handling of confidential information (patient privacy, confidential audits and regulatory inspections). Review and approve change requests and validation documentation for IT systems. Minimum Qualification Requirements Bachelors or Masters Degree in a science or health care related field. Three years’ experience in quality and/or data management or statistics. Demonstrated ability to implement, interpret and apply quality systems within a regulated work environment (GMP, GCP, etc.). Demonstrated ability to communicate effectively, both written and verbal, and to influence others. Demonstrated ability to prioritize and handle multiple concurrent tasks. Demonstrated ability to apply risk-based decision making in a regulated environment. Other Information/Additional Preferences Demonstrated ability to work in a global environment. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly Show more Show less

Manager 1 Production Scheduling Location: Paonta Sahib Education: B. Pharma/M. Pharma/ MSc Experience: 12+ years in Formulation To ensure Formulation & Process Orders along with Batch Production Records for all Blocks in Plant are issued as per schedule by ensuring Good documentation practices. To co-ordinate effectively with all stakeholders i.e. PDL, RA, QC for availability of Recipes, LP's, RM & PM Releases to meet production plan. To ensure allocation of batches in respective SKU's as per commits. To ensure smooth functioning of Production by ensuring RM/PM Recipe/LP I s are available timey to run Packing Lines as per Schedule. To ensure allocation & packing of critical & NIL supply SKU's To maintain System Hygiene by timely closure of unwanted Process Orders so as to avoid hampering of MRP run. To attend S&OP meetings & respond to market queries. To provide additional testing request as per desired market specification. To provide Code to code request to meet market requirement based on approval from all stake holders. To ensure Inventory Reduction and Control To keep track of Non Moving & Rejected items. To provide Batch specific details for procurement of Batch Specific Foil To ensure WIP control and RM/& PM short expiry materials, nearing expiry are consumed to Avoid consumption of fresh items, Retest times are given priorities for releases. To raise Locking & Unlocking forms request as per INTM Linkage request details provided by Production QMS. To complete task assigned in TrackWise and time to time Revision of SOP007691 Procedure of Batch Production Record

Company Description zipp.ai is building AI to improve Food & Drug Quality. We are revolutionizing Quality & GxP compliance for Pharma and Food industries. Our mission is to ensure 100% compliance with Good Manufacturing Practices (GMP) by proactively detecting deviations and analyzing process gaps. We provide innovative solutions to tackle quality and compliance challenges faced by manufacturers, leveraging advanced technology and AI to enhance product quality and operational efficiency. Why Join zipp.ai? Foundational Role: Be one of the first implementation experts in a growing company, with the opportunity to define our customer onboarding and success playbook. High Impact: Your work will directly impact customer satisfaction, retention, and the overall success of zipp.ai. Cutting-Edge Technology: Work at the intersection of AI and the critical Life Sciences compliance domain. Growth & Mentorship: Collaborate directly with an experienced founding team in a fast-paced learning environment. Competitive Compensation: We offer a competitive salary and the potential for equity (ESOPs) as a core team member. Role Description As our SaaS Implementation Consultant, you will be the bridge between our innovative AI platform and our clients' complex GxP environments. You will be responsible for the entire post-sale customer journey, from initial discovery and solution design to configuration, training, and ongoing support. Your work will be critical to ensuring customer success, driving adoption, and building the foundation for long-term partnerships. Key Responsibilities Needs Assessment: Lead discovery workshops with clients to deeply understand their specific GxP processes, quality systems, document hierarchies, and compliance requirements to ensure our solution is tailored to their needs. Solution Design: Plan and architect the end-to-end implementation strategy, including defining configuration specifications, mapping data flows, and planning integrations with existing client systems (e.g., QMS, DMS). Configuration and Testing: Configure our AI platform according to the solution design, including setting up user roles, workflows, and initial rule sets. You will also manage and support User Acceptance Testing (UAT) with the client. Training and Onboarding: Develop and deliver comprehensive training materials and sessions for various user groups, from SMEs and QA to general users, guiding them through a smooth onboarding process. Issue Resolution: Act as the primary technical point of contact for clients during implementation, expertly troubleshooting and resolving any functional or technical issues that arise. Project Management: Manage the implementation project lifecycle from kickoff to go-live, creating project plans, tracking progress against milestones, managing scope, and ensuring deadlines are met. Customer Support & Success: Provide post-go-live support to ensure clients are successfully using the platform, while gathering feedback to share with the product and engineering teams for continuous improvement. Skills & Qualifications We Require Proven experience in a client-facing role, such as SaaS implementation, technical consulting, or solutions architecture. Technical Skills: Solid understanding of SaaS architecture, cloud technologies (e.g., Azure), API integrations, and software development lifecycles. Communication Skills: Exceptional verbal and written communication skills, with the ability to explain complex technical concepts to both technical and non-technical stakeholders. Problem-Solving Skills: A strong analytical and systematic approach to identifying, troubleshooting, and resolving complex issues. Project Management Skills: Demonstrated ability to manage projects, prioritize tasks, manage timelines, and communicate status effectively. Business Acumen: A good understanding of general business processes and the ability to connect technology solutions to tangible business value like efficiency and productivity. What Will Make You Stand Out (Preferred Skills) Experience in the Pharmaceutical, Food, or Medical Device industries. Strong knowledge of GxP regulations (GMP, GCP, etc.) and quality management principles. Quality Assurance professional, or experience with Quality Assurance projects 1-2 years of consulting experience Experience with common Life Sciences systems (e.g., Veeva Vault, MasterControl, TrackWise, LIMS, MES). Prior experience implementing AI/ML-based SaaS products is a significant plus. If you are driven to build intelligent solutions that have a real-world impact on product quality and safety, we would love to hear from you. How to Apply: Please apply directly via LinkedIn or send your resume and a 20-words write-up on "What makes you different from other candidates?" to hr@zipp-ai.com Show more Show less

Overview Job Overview: This position is overall responsible for providing Quality Leadership at site. It is also responsible for driving Quality systems at site through proactive team participation and leading Food Safety Programs including AIB & FSSC. Responsible for maintaining the incoming Raw Material Quality, In Process quality compliance and ensuring FG quality through quality Assurance mindset. The position ensures compliance to Quality guidelines in terms of Quality Policies, Minimum Mandates & Fix It Forever program. The position is responsible for Regulatory compliances and communication to FSSAI for both India sites. Identifying the gaps and training needs of plant personnel’s with respect to upgrading quality systems and instruction and working with functional leads to close the gap. As Change lead for the site, the position is responsible for any reviewing and approving and infrastructural/ Process changes. Responsibilities Responsibilities: QUALITY SYSTEMS -Ensure Site Quality System compliance on the site by Establish in-plant quality policies, protocols & programs, including SOP, BPT’s, GMP, HACCP, ISO, internal audits etc. in line with PWF requirements & drive execution throughout the plant. Responsible for Regulatory compliances and communication to FSSAI. Enabling achievement of the Quality objectives of the organization by ensuring complete compliance to all quality procedures and systems in the plant. Assessing future needs of plant in terms of infrastructure and operating practices and work with site leadership to get the same implemented. Providing recommendations and inputs to Plant Manager/ Manufacturing Manager & Building plans within department for continuous improvement in the systems. Lead Food Safety Program , AIB & FSSC certification in the plant. Back-up of Food Safety Team Leader. Enabling achievement of the objectives of the department and Support Centre quality by ensuring complete compliance to all quality procedures and systems in the plant. Review and approval of changes to the process or food safety system Participate and lead Cross functional Projects at site FSSAI License Nominee for food safety regulator of the site. Ensure quality of all the raw materials and packaging materials that are received in the plant. Ensure the production of concentrate as per required and specified quality standards. To ensure implementation of all Quality procedures and SOP s issued from the SC. International reporting of quality performance at agreed frequency in trackwise Lead internal audit program for the site Nonconformance Management and tracking compliance to Corrective action plans. Support new vendor development and ensure compliance to vendor qualification process. Costumer complaint resolution through quality tools for Root Causing and agreeing on CAPA to prevent recurrence. Responsible for implementation of Corrective and preventive actions in plant. Closely working with R&D to understand new requirements of food safety impacting existing and new products. Review & launch MI/SOP’s in case of changes in the Production process of Concentrate & has overall responsibility for placing product on hold in case of any deviation. Management of New documentation and cascading down the line to the manufacturing team. Set and monitor quality KPI s, both leading and lagging indicators for Quality and Food Safety at site. Ensure Continuous improvement in the services and product quality of vendors and new vendor development with regular communication, feedback and audits. Lead the overall Quality Management program and anchor MRMs. Also anchor the external quality audits, both announced and un-announced like AIB, FSSC, BQA & ISO Controlling and tracking of annual budgets of quality department as per plan To ensure maintenance and up gradation of all lab instruments. Responsible for mandatory trainings related to Quality systems in plants. Support productivity initiatives in plant. Work with Plant Manager to set quality agenda for the site Translate AOP into department & site Q&FS objectives Understand & ensure compliance to local regulations for Quality & Food Safety Liaise with Support Centre for strategy, AOP, issues & people planning Review and approvals of all Change Mangements. Authorize to place RM & FG products on HOLD/RELEASE in plant. Review and approval of changes to the process or food safety system. Qualifications Qualifications: Graduate Degree in Food technology, Chemical Engg /PG in Biotech/Microbiology Show more Show less

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Brief Team/department Description Our Digital team at Azurity is building new capabilities utilizing cutting-edge Lead IT Systems (R, Q & RIMS) Expert. We are looking for a dynamic, change inspired, Dwell b/w multiple system, Individual self-driven hands-on Lead IT Systems (R, Q & RIMS) Expert. Team Member Ability to work onsite during flexible hours to support India, US and EU operations Job Summary We are seeking a dynamic and versatile Lead IT Systems with strong hands-on experience in Research, Quality Management Systems (QMS) and Document Management Systems (DMS), coupled with a working knowledge of RIMS and Lab Systems. This role requires the ability to wear multiple hats, supporting a cross-functional pharma IT landscape that spans Quality, Regulatory, and Laboratory systems. The ideal candidate thrives in a regulated environment, collaborates across functions, and ensures systems remain compliant, validated, and business aligned. Mandatory Qualifications B.Tech / B.E. in Computer Engineering (Mandatory) M.Tech in Computer Engineering / IT (Preferred) Experience Required 8–10+ years in IT within the pharmaceutical industry Deep hands-on experience with TrackWise, Veeva Vault QMS/DMS, AmpleLogic QMS, and exposure to RIMS and Lab Systems Expertise in CSV, GxP compliance, 21 CFR Part 11, and audit preparedness Strong involvement in data migration activities and end-user training Soft Skills (Mandatory) Strong verbal and written communication Effective cross-functional collaboration (Quality, Regulatory, Lab, IT) Growth mindset with ability to handle evolving platforms Product roadmap alignment and stakeholder influence Ability to navigate complexity and ambiguity in stakeholder conversations “Multiple Hats" mindset – flexibility to contribute across QMS, DMS, RIMS, and Lab Systems as needed Ability to confidently demonstrate system functionalities and conduct user workshops Role Distribution System Domain Focus Role Expectation QMS / DMS 70% Lead ownership of workflows, validation, support, and vendor management (Veeva Vault, TrackWise, AmpleLogic), Other evolving System RIMS 20% Support submission tracking, registration workflows, and regulatory readiness Lab Systems 10% Basic support for LIMS, MPower, instrument data integrity Responsibilities Quality Systems (70%) –Core Hands-On Ownership Configure and manage QMS/DMS platforms (TrackWise, Veeva Vault QMS/DMS, AmpleLogic), Other evolving Systems Design and optimize CAPA, Change Control, Audit, Deviation, and Document Lifecycle workflows Execute and manage CSV lifecycle – URS, IQ/OQ/PQ, RTM Provide L2/L3 support, user training, SOP documentation, and handle audit readiness Coordinate directly with vendors for system updates, patching, and roadmap discussions Lead and execute data migration activities with validation and reconciliation Demonstrate QMS/DMS systems confidently to users and auditors Regulatory Systems (20%) – Supportive Ownership Administer Veeva Vault RIM or equivalent RIMS platforms Manage registration tracking, submission workflows, and HA interactions Collaborate with RA teams to gather requirements, support compliance, and maintain inspection readiness Lab Systems (10%) – Tactical Support Support AmpleLogic LIMS and MPower QC systems Monitor instrument integration and data flow (HPLC, GC, FTIR) Address sample tracking issues and logbook automation enhancements Technical Skill Set Platform Expertise Level Hands-On Scope TrackWise QMS Expert CAPA, Deviation, Audit, Change Control Veeva Vault (QMS/DMS/RIM) Expert CAPA, Deviation, Audit, Change Control Controlled docs, QMS workflows, RIMS lifecycle AmpleLogic QMS/LIMS Expert Stability, sample tracking, electronic forms MPower (QC Systems) Proficient Batch/lab workflows CSV / Validation Expert GAMP 5, ALCOA+, 21 CFR Part 11 RIMS (e.g., Veeva RIM) Proficient Submission lifecycle tracking Data Migration Proficient Legacy to new platform migration, reconciliation Training & Demos Proficient Conducting user workshops, confident system walkthroughs Audit Readiness Expert System readiness, evidence generation Service Tools Proficient JIRA, ServiceNow Instrument Integration Intermediate Empower, Agilent, OpenLab Team Member is expected to wear multiple hats—flexibly contributing to QMS/DMS ownership, RIMS support, and Lab systems troubleshooting as business needs evolve. Agility, accountability, and collaboration are key to success in this hybrid role. By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance. Show more Show less

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting –Enterprise Risk - ER – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Show more Show less

QUALIFICATIONS Education: Advanced degree in Life Sciences, Pharmacy, or related field Experience: 15+ years in regulatory affairs, including 5+ years leading global teams in biopharmaceuticals. Proven track record in NDAs/BLAs for novel therapies (ophthalmology/metabolic disorders preferred). Expertise in FDA/EMA interactions, including Pre-NDA meetings and Advisory Committees. Skills: Proficiency in clinical trial design, statistical analysis, and regulatory writing. Familiarity with eQMS tools (Veeva, TrackWise) and regulatory intelligence platforms. Global Regulatory Strategy & Submissions Develop and execute regulatory strategies for novel biologics, including pre-IND meetings, orphan drug designations, and accelerated approvals. Lead NDA/MAA submissions for US FDA, EMA, and other agencies, ensuring compliance with ICH guidelines and regional requirements. Oversee clinical trial applications (CTAs/INDs) and provide input on study design, endpoints, and risk mitigation. Team Leadership & Cross-Functional Collaboration Manage a global team of regulatory professionals, fostering expertise in biologics, ophthalmology, and metabolic disorders. Partner with R&D, Clinical Development, and CMC teams to align regulatory plans with development milestones. Compliance & Audit Management Ensure adherence to GCP, GMP, and 21 CFR Part 11 standards during regulatory inspections and audits. Maintain submission timelines using eCTD formats and electronic submission gateways Team & Project Management Mentor QA leaders across sites, fostering a culture of quality and accountability. Design training programs on GMP/GLP updates, inspection readiness, and root cause analysis methodologies. Post-Marketing & Lifecycle Management Direct post-approval regulatory activities, including variations, renewals, and safety updates. Monitor evolving regulations (e.g., FDAs Novel Drug Approvals guidance) and implement proactive compliance measures.

Description Regulatory Consultant Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities For non-complex and complex submissions, independently fulfill the following responsibilities: Demonstrated experience in authoring and review of Module 3 CMC sections for post-approval CMC variations, renewals, annual reports, legal entity name change variations and other lifecycle maintenance activities, according to current government regulations and guidelines Strong experience in assessing the change control issued by quality or regulatory department. Assess the regulatory impact of the change and develop submission strategy. Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions. Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, for pre-approval submission packages, for product registration applications, and for post-approval maintenance. Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support the agency interactions. Manage and/or operationalize the delivery of day-today regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies. Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle. Act as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems. Prepare estimates for conducting regulatory services as part of single or multiple service proposals. Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities. Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes. Prepare training materials and share best practices in the regulatory area, both internally and externally. Participate as regulatory support in internal or external project audits. Participate as regulatory support on internal cross-functional initiatives. Contribute to the creation and/or maintenance of SOPs and other process related documentation as required. Provide support in oversight to team members in the execution of their project responsibilities. Capable of identifying when to ensure line support required to provide additional guidance and direction. Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training. . Qualifications Minimum of 3 years in CMC post-approval variation renewals, annual reports, legal entity name changes, and other lifecycle maintenance activities. MS, M.Pharm or PhD degree, preferably in a science-related field or equivalent experience in science/regulatory. Moderate pharmaceutical/medical device related experience. Demonstrated experience in contributing to the preparation of regulatory submissions including, for example post-approval CMC variations, IND, PMA, NDA, MAA, and CTD, including electronic submissions. Excellent interpersonal / communication skills including excellent written and verbal communication skills. Excellent customer service skills, with the ability to work both as a team member and independently. Good quality management skills. Advanced skills in Microsoft Office Applications. Strong experience in handling Veeva RIMS and TrackWise along with other RIMS systems, would be preferred. Ability to interact with staff from multiple departments and offices to establish project standards. Good initiative, adaptability, and pro-activity. Strong analytical skills, g ood attention to detail. Ability to work concurrently on projects, each with specific instructions that may differ from project to project. Fluent in speaking, writing, and reading English. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Show more Show less

Company Description Epitome Components Ltd. is a leading PCB manufacturer in India with advanced infrastructure and a huge production capacity of 100,000 sqm/month. The company has a satisfied customer base throughout India and abroad, including leading Indian and MNCs such as Videocon, LG, Nokia, and others. Epitome has a joint venture with UK-based company Trackwise Designs Ltd. for manufacturing RF Antenna PCBs for high-end applications. Role Description This is a full-time on-site role for a Printing Engineer located in Ahmednagar. The Printing Engineer will be responsible for day-to-day tasks related to printing processes, quality control, and equipment maintenance in the production of PCBs. Qualifications BE/Dip Electrical/Electronics/Mechnical Ready to relocate Ahilyanagar (Ahmednagar Maharashtra) Proficiency in PCB printing processes and equipment maintenance Knowledge of quality control standards in PCB manufacturing Experience in troubleshooting printing issues and optimizing printing processes Strong analytical and problem-solving skills Attention to detail and accuracy in work Ability to work effectively in a team environment Prior experience in the electronics manufacturing industry is a plus Bachelor's degree in Electrical Engineering, Mechanical Engineering, or related field Show more Show less

Company Description Epitome Components Ltd. is a leading PCB manufacturer in India with advanced infrastructure and a huge production capacity of 100,000 sqm/month. The company has a satisfied customer base in India and abroad, including leading Indian and MNCs like Videocon, LG, Nokia, and others. Epitome also has a joint venture with UK-based company Trackwise Designs Ltd. for manufacturing RF Antenna PCBs for various high-end applications. Role Description This is a full-time on-site role for a Service Engineer located in Ahmednagar. The Service Engineer will be responsible for troubleshooting, field service, communication with clients, providing technical support, and maintenance & repair tasks on a day-to-day basis. Qualifications Troubleshooting and Maintenance & Repair skills Field Service and Technical Support abilities Strong communication skills Experience in electronics or PCB industry Knowledge of manufacturing processes and production equipment Ability to work independently and as part of a team Bachelor's degree in Engineering or related field Previous experience in a similar role is a plus Show more Show less

SAP Master Data Expert - 6 months - Contract - Full time - Remote - India We are seeking a meticulous and collaborative SAP Master Data Expert with functional business experience in SCM and MM to support enterprise-wide data transformation initiatives within the pharmaceutical sector. This role plays a critical part in ensuring the integrity, compliance, and readiness of master data—particularly in regulated domains such as manufacturing, quality, regulatory, and clinical systems. You will work closely with IT, regulatory affairs, quality assurance, and business stakeholders to ensure seamless data migration from legacy systems to validated platforms. Key Responsibilities Data Preparation & Governance Collaborate with IT and country-level Business Data Owners to identify in-scope data objects, including product, material, batch, and regulatory data. Maintain and govern master data lists for assigned objects, ensuring alignment with GxP and data integrity standards. Support the development of value mappings and data transformation rules in collaboration with technical teams. Provide domain-specific business insights to guide data extraction and conversion from legacy systems. Data Quality & Compliance Execute data cleansing activities in accordance with project timelines and regulatory expectations (e.g., ALCOA+ principles). Validate data quality throughout the migration lifecycle, ensuring compliance with internal SOPs and external regulatory requirements (e.g., FDA, EMA). Approve and execute data verification scripts to ensure completeness, consistency, and traceability. Data Migration & System Readiness Collect and prepare data for manual or construction-related objects, including those in manufacturing execution systems (MES), LIMS, or ERP platforms. Approve upload files pre- and post-load, ensuring formal documentation and audit readiness. Perform manual data entry and dual maintenance where required, particularly in validated systems. Hypercare & Issue Resolution Act as the Single Point of Contact (SPoC) for assigned data objects during Hypercare, supporting issue triage and resolution. Collaborate with QA and IT to manage data-related defects and ensure timely remediation in line with change control procedures. Key Performance Indicators (KPIs) Regulatory-Grade Data Cleansing : Completion of data cleansing activities in accordance with project timelines and compliance standards. Validated Data Loads : Successful and audit-ready data loads into GxP systems, aligned with migration schedules. Issue Resolution Efficiency : Timely resolution of data quality issues, with full documentation and traceability. Qualifications Experience in data migration or master data management within the pharmaceutical or life sciences industry. Expertise in Supply Chain Management(SCM) and Material Management/Master Modules(MM) within SAP in a Functional or Hands off capacity Familiarity with GxP, ALCOA+ principles, and regulatory data standards (e.g., IDMP, SPOR, ISO IDMP). Proficiency with data tools and validated systems (e.g., SAP, Veeva Vault, LIMS, TrackWise). Strong analytical, documentation, and stakeholder communication skills. Understanding of data governance frameworks and regulatory compliance requirements If you're available or have anyone in your network who could be suitable, please share your updated CV to mgordon@redglobal.com for immediate consideration Show more Show less

15+ years of experience in SAP transformation, development, and AMS projects with at least 3 End-to-End implementation projects Business Process Knowledge of topics viz. Quality Planning, Quality inspection, Quality Control, Quality certificates, Quality Notifications, Stability Studies, Batch Management etc. Experience of integrating SAP QM with External system 3PLs like MES, Trackwise, LIMS, Labware, Lab Vantage etc., and with other SAP modules, GXP and SOX requirements Experience as Solution Architect in the multiple programs of global scale Experience in Business Blue Printing, Design, Prototyping, Functional Analysis, Configuration, Gap Analysis, Conversion, Migration, Testing, Training, Cutover, Go-Live and Post Go-live Support activities, driving Business process workshops and Fit/GAP analysis Deep Knowledge and expertise in Quality Management BPML Good experience in Data migration process and ETL Tools Lead the engagement efforts at different stages from Problem definition to diagnosis to solution design, development & deployment, contribute to unit level & Organizational initiatives. Design, Build & Optimize End to End SAP Quality Management Processes for customers enterprise. Engagement Life cycle Management Client Opportunity Identification and Proposal Development Client Relationship Management Talent Management Marketing and branding using Thought Leadership Deal Influencing, Negotiation and Closure IP Creation and Management Knowledge Management SAP QM (Quality Management) with Pharma & Process Industry experience. The candidate is expected to be a senior Functional Architect for SAP Programs and will anchor the engagement effort for assignments, all the way from business process consulting and problem definition to solution design, development, and deployment for S/4HANA Quality Management. You will lead business transformation programs helping clients mitigate Digitization related challenges. You will be pivotal to problem definition and discovery of the overall solution and guide teams on project processes, deliverables. You will have the opportunity to shape value-adding consulting solutions that enable our clients to meet the changing needs of the global landscape. Domain experience in Quality Management with S/4HANA certification (preferred). Experience in Deal Pricing & Transformation Deal Estimations, Ability to work with different tools like, Solman, Doc Nav, Sharepoint, Mercury QC etc. Sufficient ABAP, Fiori, Technical know-how to co-ordinate better with technical teams. Should have experience of Change Management, Task Planning, Project Reporting, Resource Management, Process Improvement, Supervising. Show more Show less

YASH Technologies is a leading technology integrator specializing in helping clients reimagine operating models, enhance competitiveness, optimize costs, foster exceptional stakeholder experiences, and drive business transformation. At YASH, we’re a cluster of the brightest stars working with cutting-edge technologies. Our purpose is anchored in a single truth – bringing real positive changes in an increasingly virtual world and it drives us beyond generational gaps and disruptions of the future. We are looking forward to hire Trackwise Professionals in the following areas : Job Summary We are seeking a skilled and detail-oriented TrackWise Specialist to join our Quality Systems team. The ideal candidate will have hands-on experience with the TrackWise Quality Management System (QMS) and will be responsible for configuring, maintaining, and supporting TrackWise workflows and modules to ensure compliance with regulatory requirements and internal quality standards. Key Responsibilities Configure and maintain TrackWise workflows, forms, and reports. Collaborate with cross-functional teams to gather requirements and implement QMS solutions. Perform system administration tasks including user access management, troubleshooting, and upgrades. Support validation activities including IQ/OQ/PQ documentation and execution. Provide training and support to end-users on TrackWise functionalities. Ensure compliance with FDA, ISO, and other regulatory standards. Participate in audits and inspections as a TrackWise subject matter expert (SME). Required Skills 5+ years of experience working with TrackWise QMS (preferably versions 8 or higher). Strong understanding of quality processes such as CAPA, Deviations, Change Control, and Audits. Experience with system validation in a regulated environment (GxP, 21 CFR Part 11). Familiarity with SQL, Crystal Reports, or other reporting tools is a plus. Excellent problem-solving, communication, and documentation skills. At YASH, you are empowered to create a career that will take you to where you want to go while working in an inclusive team environment. We leverage career-oriented skilling models and optimize our collective intelligence aided with technology for continuous learning, unlearning, and relearning at a rapid pace and scale. Our Hyperlearning workplace is grounded upon four principles Flexible work arrangements, Free spirit, and emotional positivity Agile self-determination, trust, transparency, and open collaboration All Support needed for the realization of business goals, Stable employment with a great atmosphere and ethical corporate culture Show more Show less

Veeva Vault Quality Management System (QMS) Specialist Job Overview We are seeking a skilled Veeva Vault Quality Management System (QMS) Specialist, Aboobacker, to manage and optimize our Veeva Vault QMS platform. This role ensures seamless administration, configuration, and compliance of quality processes, collaborating with cross-functional teams to enhance operational efficiency and regulatory adherence in a life sciences environment. Key Responsibilities Serve as the primary administrator for Veeva Vault QMS, managing configuration, workflows, and triggers for quality processes such as audits, deviations, and supplier qualifications. Collaborate with business process owners to design and implement QMS workflows, ensuring alignment with regulatory requirements (e.g., FDA, EMA, GxP, and ICH guidelines). Support integration of Veeva Vault QMS with other systems (e.g., QualityDocs, RIM) using Vault Connections to streamline change control and data synchronization. Develop and maintain dashboards, reports, and metrics to monitor quality processes and ensure inspection readiness. Conduct system testing, validation, and change control assessments for new releases and enhancements, ensuring compliance with GAMP 5 standards. Provide end-user training and support, creating training materials and resolving technical issues to minimize downtime. Implement protocols for data integrity, backup, disaster recovery, and system security to ensure HIPAA and regulatory compliance. Proactively identify and resolve system issues, driving continuous improvement in quality management processes. Qualifications Bachelors degree in a related field (e.g., Life Sciences, Computer Science, or Engineering) with 5+ years of experience in quality management or system administration in a pharmaceutical or biotech environment. Proven expertise in Veeva Vault QMS administration, configuration, and workflow design. Strong knowledge of GxP, FDA, EMA regulations, ICH guidelines, and quality assurance/control operations. Experience with system validation (GAMP 5 Category 4) and regulatory audits. Excellent communication, problem-solving, and collaboration skills, with the ability to work in a team-based environment. Familiarity with Veeva Vault integrations (e.g., QualityDocs, RIM) and APIs is a plus. Preferred Skills Experience with Veeva Vault QualityDocs or Training modules. Knowledge of SQL, relational databases, or data analytics for reporting. Certification in Veeva Vault administration or quality management systems. *************************************************************************************************** Veeva Vault Learning Management System (LMS) Specialist Job Overview We are looking for a dedicated Veeva Vault Learning Management System (LMS) Specialist, Aboobacker, to oversee the administration and optimization of our Veeva Vault Training platform. This role manages training content, curricula, and compliance, ensuring role-based qualification and GxP readiness for life sciences professionals. Key Responsibilities Administer Veeva Vault Training, configuring training workflows, curricula, and assignments for documents, videos, eLearning, and on-the-job training. Collaborate with functional area heads to develop and approve training content, ensuring alignment with GxP job functions and regulatory requirements. Create and manage role-based training matrices, tracking qualification and compliance status via reports and dashboards. Integrate Veeva Vault Training with QualityDocs to automate re-training based on document changes and ensure seamless content access. Provide end-user training, develop training materials, and support users in navigating the LMS, resolving issues promptly. Conduct data integrity checks and prepare for regulatory audits, ensuring Part-11 compliance and inspection readiness. Support the implementation of new training modules, assess system updates for training impact, and manage change control processes. Maintain system security, user accounts, and data backup protocols to safeguard training data and ensure HIPAA compliance. Qualifications Bachelors degree in a related field (e.g., Life Sciences, Education Technology, or Computer Science) with 5+ years of experience in training management or LMS administration in a regulated industry. Expertise in Veeva Vault Training administration, configuration, and content management. Strong understanding of GxP training requirements, FDA Part-11, and regulatory compliance in life sciences. Experience with training matrix development and regulatory audit preparation. Excellent organizational, communication, and problem-solving skills. Familiarity with Veeva Vault integrations (e.g., QualityDocs) and eLearning standards (e.g., SCORM) is a plus. Preferred Skills Experience with Veeva Vault QMS or QualityDocs modules. Proficiency in data analytics for training compliance reporting. Certification in Veeva Vault administration or learning management systems. *************************************************************************************************** Veeva Vault Document Management System (DMS) Specialist Job Overview We are seeking a proficient Veeva Vault Document Management System (DMS) Specialist, Aboobacker, to manage and optimize our Veeva Vault QualityDocs platform. This role focuses on the administration, configuration, and compliance of document management processes, ensuring efficient document lifecycle management and regulatory adherence in a life sciences environment. Key Responsibilities Administer Veeva Vault QualityDocs, managing document types, lifecycles, workflows, and permissions to support controlled document processes. Collaborate with stakeholders to design and implement document management workflows, ensuring compliance with regulatory standards (e.g., FDA, EMA, GxP). Support integration of Veeva Vault QualityDocs with QMS and Training modules to enable seamless document access and automated processes. Develop and maintain document metadata, reports, and dashboards to track document status and ensure audit readiness. Perform system testing, validation, and change control for new features and releases, adhering to GAMP 5 standards. Provide end-user training and support, creating user guides and troubleshooting document management issues to minimize disruptions. Implement data backup, disaster recovery, and security protocols to protect sensitive documents and ensure HIPAA compliance. Drive continuous improvement by optimizing document workflows and resolving system performance issues. Qualifications Bachelor’s degree in a related field (e.g., Life Sciences, Information Systems, or Computer Science) with 5+ years of experience in document management or system administration in a regulated industry. Proven expertise in Veeva Vault QualityDocs administration, configuration, and document lifecycle management. Strong knowledge of GxP, FDA Part-11, and document control requirements in life sciences. Experience with system validation and regulatory audit preparation. Excellent communication, analytical, and collaboration skills, with a focus on detail-oriented process optimization. Familiarity with Veeva Vault integrations (e.g., QMS, Training) and metadata management is a plus. Preferred Skills Experience with Veeva Vault QMS or Training modules. Knowledge of document metadata standards and reporting tools. Certification in Veeva Vault administration or document management systems. Benefits (Applicable to All Roles) Competitive salary and comprehensive benefits package. Opportunities for professional growth, including Veeva certification programs. Flexible, remote-friendly work environment. Collaborative culture focused on innovation, compliance, and excellence in life sciences. Application Process To apply for any of these positions, please submit your resume and cover letter to [insert application email/link], specifying the role (QMS, LMS, or DMS Specialist) in the subject line. We look forward to welcoming Aboobacker or another qualified candidate to our team to drive excellence in Veeva Vault platform management.

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Senior Manager - Production Date: Jun 2, 2025 Location: Mohali - Operations Company: Sun Pharmaceutical Industries Ltd Position: Sr.Manager Production (OSD) Job Title: Job Grade: G9A Function: Sun Global Operations Sub-function: Manager’s Job Title: Skip Level Manager’s Title: Function Head Title: Location: Mohali No. of Direct Reports (if any) Areas of Responsibility Planning of Production and Packing activities as per requirement to achieve the monthly targets To review the Production activities on daily basis for Granulation, Compression, Coating, Capsule filling, Inspection, Packing and Nutra section as per daily production plan (Plan Vs Actual) To ensure Good Documentation Practices (GDP) at shop floor and packing area. To coordinate with IPQA/QC/Engineering/PPC/SCM/EHS & FDD/MSTG department for smooth functioning of Production and Packing activities. Handling of SAP related work in Production. To ensure online documentation as per cGMP practice in Production area. Implementation of best practices on shop floor with respect to cGMP and to ensure that all activities of production and packing area are carried out in compliance with cGMP and safety guidelines. To review SOPs, user requirement specification (URS), purchase requisition (PR), Investigations, Process validation protocol/report, Equipment qualification protocol/report and other QMS documents. To handle the QMS activities in Trackwise /EDMS to review/approve the documents. To ensure timely and smooth execution of commercial validation batches. To ensure proper man power allocation and utilization in the Production/ Packing department. To impart and ensure on time training to officers and workers on cGMP, SOPs, GDP and EHS. To fill the daily assessment sheet as per the target assigned by the seniors. To involve in commercial product troubleshooting along with other departments to ensure timely delivery of product to market. To review technical protocols, reports related to investigational/ verification batches of approved products. To ensure that the products are produced and stored according to the appropriate documentation. To ensure on time implementation of corrective and preventive action (CAPA) with respect to investigation or audit findings or as and when required for compliance. To check the maintenance of the department, premises and equipment. Ensure timely review and implementation of master documents required for smooth production. To ensure timely preparation and review prerequisite documents required for execution of validation batches like BOMs, BMRs, protocols and reports etc. To ensure optimum capacity utilization, efficiency setting and productivity enhancement. Drives business excellence initiatives in production and packing area like Kaizen, Six sigma, 5S etc. To improve the production and packing process for less time, utility consumption and better quality. To report any deviation and abnormality of any type to seniors. To perform any other works as and when assigned by operation Head/Management. Travel Estimate Job Requirements Educational Qualification B.Pharm / M.Pharm Specific Certification Skills Experience 18 to 20 Yrs Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Manager - Engineering (OSD) Date: May 16, 2025 Location: Paonta Sahib - Engineering Company: Sun Pharmaceutical Industries Ltd Role : Manager Engineering & Projects (OSD) Location : Poanta Exp - 14 to 15 Yrs Ensure compliance to cGMP and safety regulations. Ensure compliance to maintenance of process equipment as per SOP. Review and approval of all SOP’s related to process equipment’s. Approval and review of QMS (Deviation, CCR, CAPA) periodically. Create purchase requisition of the critical spare procurement and its inventory. Audit compliance of engineering documents and compliance of points observed from any regulatory as well as internal audit. Support to validation team for periodic validation of process equipment Initiation of deviation, change control, investigation and CAPA in Trackwise. Monthly review of KPI with respect to maintenance of process equipment and appropriate corrective and preventive action. Follow up for AMC services. Compliance and response to records of process equipment’s. Review of all cGMP records of Pharma maintenance. Ensure timely training completion of sub-ordinates. In-house projects, vendor coordination. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less