94 Trackwise Jobs - Page 3

Job Summary We are seeking a Product Analyst with 2 to 5 years of experience to join our team in a hybrid work model. The ideal candidate will have expertise in TW-Basic Config and Trackwise On-prem with a preference for experience in the Medical Devices domain. This role involves analyzing product performance and contributing to product development strategies ensuring alignment with company goals. Responsibilities Analyze product performance data to identify trends and insights that drive product improvements. Collaborate with cross-functional teams to gather and document product requirements. Provide technical expertise in TW-Basic Config and Trackwise On-prem to support product development. Develop and maintain product documentation to ensure clarity and consistency. Conduct market research to understand customer needs and competitive landscape. Assist in the creation of product roadmaps and strategies to align with business objectives. Monitor product lifecycle and recommend enhancements based on user feedback. Support the implementation of product changes and updates to improve user experience. Communicate effectively with stakeholders to ensure alignment on product goals and priorities. Utilize data analytics tools to measure product success and inform decision-making. Ensure compliance with industry standards and regulations particularly in the Medical Devices domain. Participate in product testing and quality assurance to ensure high standards are met. Contribute to the continuous improvement of product management processes. Qualifications Possess strong analytical skills with the ability to interpret complex data sets. Demonstrate proficiency in TW-Basic Config and Trackwise On-prem. Exhibit excellent communication skills in English both written and spoken. Show a keen understanding of the Medical Devices industry is a plus. Display the ability to work collaboratively in a hybrid work environment. Have a proactive approach to problem-solving and decision-making. Maintain a customer-focused mindset to enhance product offerings. 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. 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 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, 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. 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 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, 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. 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 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, 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. 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 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, 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. 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 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, 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. 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 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, 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

Be the First to Apply Job Description Business: PPL Digwal Department: TSD Location: Digwal Job Overview: To perform Production actives as per GMP & Safety Travel Requirements : NA Reporting Structure Reports to Manager - TSD Key Stakeholders Internal: QC, QA, SCM & Safety External: NA Experience 6-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities Key Roles & Responsibilities Initiation of change controls Prepare the new BMRs, BPRs & ECRs as per requirement. Revision of existing BMRs, BPRs and ECRs as per requirement. Monitor & close the CAPAs. To plan the daily activities in the concerned production blocks. Close the pre- action & post- actions related to change controls in trackwise. Initiation and of review of deviation and investigation reports. Review the executed BMRs, BPRs, ECRs etc. Indenting & receiving of new / executed BMRs, BPRs, ECRs etc. Provide the response to the internal / external parties comments & update the documents. Follow the safety precautions. Maintain discipline at the work place. Ensure effective implementation of the cGMP compliance and quality management system in the plant. Follow the cGMP system and provide the training on change documents, SOP, CAPAs related to investigations, deviation etc. as per requirement. Any other responsibilities assigned from time to time as per requirement. Qualifications Qualification : B.Sc (Chemistry) / M.Sc (Chemistry) / B.Tech (Chemical) Job Info Job Identification 5344 Posting Date 05/28/2025, 09:16 AM Apply Before 05/30/2025, 09:16 AM Degree Level Technical Diploma/A Level Job Schedule Full time Locations Piramal Enterprises Limited. Factory: Digwal, Medak, Telangana, 502321, IN Show more Show less

Title: Downstream Process Development Date: 27 May 2025 Job Location: Bangalore Pay Grade Year of Experience: Job Description Designation: Senior Research Associate Job Location: Bangalore Reporting to: Principal Investigator Job Grade: 9-II The Company Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene’s 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA. Key Result Areas Role-specific Support the DSP team with basic activities such as preparation of buffers and reagents. Designing of purification processes for novel fusion antibodies; antibody fragments and other new formats. Planning and execution of experiments associated with process development, late phase process optimization, process characterization activities. Interaction with relevant cross functional team for smooth functioning of the daily activities. Regular documentation of experiments contemporaneously in electronic lab notebook. Compilation of experimental data for further evaluation. Authoring technical reports and communicating the key findings. Participating in the weekly team meetings. Actively involve in scale-up and technology transfer to manufacturing. Troubleshoot recipes in purification systems -AKTA Pure, AKTA pilot & TFF System and develop long-term solutions for the betterment of purification platform. Enable the team in procurement of raw materials and consumables and in lab maintenance and remove any obstacle in maintaining lab inventories. Author, review protocols, reports, scale up & scale down studies, tech transfer documents, deviation & OOT reports and executed BMRs. Actively participate in quality related investigations and propose effective corrective and preventive actions. Ensure compliance in issuance of lab notebooks and archival of records such as logbooks, lab notebooks, protocols, reports, documents in electronic management system. Well versed with Track wise or similar QMS systems. Education And Experience Education Master’s degree in Life Science, Chemical Engineering, Biotechnology, or related field. Industry Experience Minimum 2-4 years of relevant practical experience in downstream process development specifically with monoclonal antibody purification Other Competencies Required For The Role Basic knowledge of downstream purification principles is essential for this role. Proficient in handling of AKTA Systems or equivalent. Experience in scale-up and tech transfer is preferable Experience in using electronic lab notebook, Electronic Database Management System (EDMS), TrackWise is preferable not mandatory. Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities. Pls visit us at https://syngeneintl.com/ to know more about us and what we do. Show more Show less

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors. As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment. Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities. The Role Veeva’s Vault Quality platform will truly change how the industry manages Quality, and we want you on our team! Veeva Systems is looking for a Project Manager who has a deep customer focus and a passion for helping customers transform the way they manage their Quality data and content within our product. This is an expert-level role that requires strong Quality domain experience, customer-focused project management, and problem-solving skills as you lead and manage large-scale global enterprise cloud software projects for Veeva. Ability to drive governance at all levels and lead a consulting team in an enterprise implementation project. We are looking for individuals with exceptional abilities in the delivery of large cloud transformation programs across the enterprise and client relationship management, and leadership skills to manage a team to grow and thrive in an environment with professional agility. If you excel in building productive relationships, aligning strategies, and excelling in a dynamic environment, then this could be an excellent match for you. Candidates must be based in Mumbai, India, or willing to relocate. What You'll Do Participate in projects at life sciences companies designing and deploying Quality systems Collaborate with the client’s leadership and other Project Managers to establish and execute a sound project management methodology for delivering Services related to the implementation of the Vault Quality suite Provide oversight for Services projects and deliver agreed services on time and with high customer satisfaction Establish close, collaborative relationships with customer stakeholders to understand and act on customer needs Drive governance and demonstrate leadership by working across customer and internal teams to support all phases and workstreams within the implementation of the Vault Quality suite of applications Manage day-to-day project activities and project administration Enable your project team to focus on solution design, prototyping, configuration, training, and documentation Mentor project team members in the Services organization and identify growth opportunities Proactively manage risk, anticipate potential problems, and identify mitigation strategies Be transparent in all communications and reflective in conducting post-project assessments — identify learnings that will help improve the overall process Establish and provide regular reporting on project status, key metrics, and deliverables, and customize to address key stakeholder groups Requirements 10+ years of direct experience leading teams working with GXP Quality software solutions across QMS, DMS, LMS, LIMS, Validation Lifecycle Management, and/or delivering project management for related services in a Life sciences organization Experience in reporting to senior/executive-level stakeholders and technology teams with superior communication skills Exceptional project management skills with the ability to prioritize and manage multiple projects in a cross-functional environment that values speed Experience working with different LMS platforms such as SuccessFactors, Compliance Wire, and Vault Training The position requires a level of confidence to hold the line with customers and internal teams and be an advocate for the project Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and quality results Ability to travel up to 20% Nice to Have Understanding of global quality requirements, compliance considerations, and processes for Quality, Content Management, life sciences GxP training compliance, as well as QC LIMS and/or Validation Experience implementing Document or Quality Management systems for life sciences as a consultant, business, or IT representative Direct experience with systems such as Veeva Vault Quality, Honeywell Sparta TrackWise, OpenText, Documentum D2, Biovia QUMAS, UL Compliance Wire, and SAP Success Factors Consulting experience Life Science, computer science, biochemical, and mechanical engineering or related degree SaaS/Cloud experience Perks & Benefits Allocations for continuous learning & development Health & wellness programs Flexible PTO Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. 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 both in 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 various high-end applications. Role Description This is a full-time on-site role as a Production Planning Engineer located in Ahmednagar. The Planning Engineer will be responsible for day-to-day tasks related to planning, analytical skills, production planning, communication, and project control within the manufacturing environment 2 to 5 Years Experience. Qualifications Planning and Production Planning skills Analytical Skills Strong communication skills Project Control capabilities Experience in the manufacturing industry is a plus Bachelor's degree in Engineering or related field Show more Show less

What will you do: Basic knowledge and understanding of complaint handling process as required by regulatory agencies. Provide updates within Trackwise on status of product field action executions and event detail information. Monitor and facilitate product return for complaint investigation and analysis, including communicating directly with customers and sales teams. May support international and domestic complaint entry. Work with internal supporting teams on quality of data coming into post market May monitor, create, and assign regulatory communications to quality specialists for resolution. What you will need: Basic Qualifications: 2+ years relevant experience required Basic knowledge and understanding of complaint handling and product field action process as required by regulatory agencies Basic knowledge on Trackwise Basic understanding of how to comply with constantly changing regulatory procedures preferred Preferred Qualifications Must possess strong interpersonal skills including written and oral communication. Must be able to bring tasks through to completion with minimal supervision. Must have the ability to prioritize work and keep detailed and confidential records. Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Show more Show less

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description: Are you a passionate, dedicated & detailed oriented professional, then the opportunity is for you to join our Quality Assurance Team at Zydus Takeda Healthcare Private Limited, Turbhe, Navi Mumbai - A joint venture of Zydus Lifesciences and Takeda Pharmaceuticals.: For more Company Details logon to -: https //www.takeda.com/en-in/who-we-are/about-zydus-takeda/: Job Title: Senior Executive / Executive - Quality Assurance Location: Navi Mumbai About the role: The role will be responsible for In-Process Quality Assurance (IPQA) responsible for monitoring and controlling the quality of products during the production process. This role ensures that manufacturing processes comply with regulatory standards and company quality policies to maintain the highest level of product integrity and safety. How you will contribute : Perform real-time monitoring of production processes to ensure adherence to quality standards. Conduct routine inspections and in-process checks to verify compliance with specifications and protocols. Collaborate with production and quality control teams to address any quality issues promptly. Identify deviations - OOS, OOT and non-conformances, and implement corrective and preventive actions (CAPA). Ensure proper documentation of all quality-related activities and maintain accurate records. Review Batch Manufacturing Records (BMRs) and Analytical data reviews. Review Validations and Qualifications activities & documents. Participate in internal audits and inspections to ensure continuous compliance with GMP, SOPs, and other regulatory requirements. Provide training and support to production staff on quality procedures and best practices. Work closely with the quality assurance team to develop and review quality-related documents, including standard operating procedures (SOPs) and batch records. Education: Post Graduate / Graduate in Science or Pharmacy from reputed institute. Hands on experience and knowledge of Quality Management System. Strong understanding of GMP, FDA regulations, and ICH, cGMP industry standards. Experience: Minimum 6 to 8 years of experience in pharma manufacturing plant preferably API Manufacturing Plant with experience of IPQA in rotational shifts. Proficiency in using quality management software and tools like Trackwise, SAP, etc. Desired Skills : Excellent observational and attention-to-detail skills. Ability to work effectively in a team-oriented, fast-paced environment. Strong problem-solving and decision-making capabilities. Good documentation and record-keeping skills. Continuous improvement mindset and ability to handle multiple tasks efficiently Locations: IND - Navi Mumbai Worker Type: Employee Worker Sub-Type: Regular Time Type: Full time Show more Show less

SAP Master Data Expert - 6 months - Contract - Full time - Remote with AdHoc Travel 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 feel this role is a good fit for you - Contact me on sozay@redglobal.com or Apply within! Show more Show less

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com . This position is based in Bengaluru and will require some on-site work. Purpose And Scope As individual contributor of a team of individuals in a specific area of digital expertise, you will be a crucial player in driving our digital initiatives forward in our agile organization. Our agile operating model consists of two components – Digital Capability and Digital Execution . Digital Execution are about aligning multiple missions around business goals and facilitating collaboration on a larger scale. Digital Capability, on the other hand, focus on the growth and development of individuals within a specific expertise area. This dual structure enables us to scale agile practices efficiently while maintaining a focus on both product development and individual skill enhancement. A Business & Technical Analyst is a multifaceted role that bridges the gap between business needs and technical solutions. This position involves analyzing and translating business requirements into technical specifications, ensuring that the solutions developed meet the business goals and user needs. The role requires a blend of business acumen, understanding of technical architectures, and the ability to communicate effectively with both business stakeholders and technical teams. You will be at the forefront of implementing innovative solutions and will have the opportunity to work on cutting-edge technologies in your field. Essential Job Responsibilities Business Requirements Analysis: Collaborate with business stakeholders to understand their needs, goals, and objectives. Analyze business processes and workflows to identify improvement opportunities and define requirements for solutions. Technical Specification Development: Translate business requirements into detailed technical specifications that guide the development of software applications, systems, or processes. Ensure that these specifications meet both the business needs and technical standards. Solution Design and Recommendation: Work with Digital and software development teams to design solutions that fulfill business requirements. Evaluate potential technical solutions for feasibility, cost-effectiveness, and alignment with business objectives. Stakeholder Collaboration: Serve as a liaison between business units and technical teams to ensure clear communication and understanding of project goals, requirements, and constraints. Facilitate meetings and discussions to gather feedback and consensus. Project Management Support: Assist in project management tasks, such as planning, scheduling, and tracking progress. Ensure that projects stay on track to meet deadlines and budget constraints. Testing and Quality Assurance: Participate in the testing of developed solutions to ensure they meet the defined requirements and standards. Assist in identifying and documenting bugs or issues for resolution. Training and Support: Develop training materials and provide support to users on new systems or applications. Ensure that end-users are equipped to use the new solutions effectively. Documentation: Create and maintain documentation related to business requirements, technical specifications, project plans, and reports to ensure knowledge is captured and shared. Qualifications Required Bachelor’s degree in relevant field, e.g., Computer Science, Data Science, Business Administration. Demonstrated experience in business analysis, technical analysis, or a related area, demonstrating a track record of bridging business needs with technical solutions. Experience with Salesforce, TrackWise Digital and Veeva platform solutions Analytical Skills: Strong analytical and problem-solving skills to understand complex business issues and develop appropriate technical solutions. Technical Knowledge: Good understanding of information technology, software development life cycles, and architectural frameworks. Familiarity with programming languages, databases, and software development tools is beneficial. Communication Skills: Excellent verbal and written communication skills, with the ability to convey technical concepts to non-technical stakeholders and vice versa. Collaboration: Ability to work effectively in a team environment, collaborating with diverse groups of stakeholders, including business users, Digital professionals, and management. Project Management: Good knowledge of Agile methodology, principles and practices. Attention to Detail: Precision in documenting requirements, specifications, and project details to ensure clarity and alignment with objectives. Adaptability: Flexibility to adapt to changing requirements, technologies, and project priorities. Experience with system integration and data migration Good Knowledge of ERP, Quality, Regulatory, Clinical systems and operations Preferred Life Sciences / Pharma industry experience Certifications in specific technologies, architecture frameworks (e.g., TOGAF), Agile delivery methodologies (e.g., SAFe) can be beneficial. Agile Champion: Adherence to DevOps principles and a proven track record with CI/CD pipelines for continuous delivery Working Environment This position is based in Bengaluru and will require some on-site work. Category PlatformX Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans Show more Show less

Purpose and Scope: Strategy Development and Execution Contributes to the implementation of 1–3-year Global, Regional Affiliate Management and Local specific objectives and plans as part of the overall PV strategy and plans. Supports in the successful execution and implementation of Global Affiliate Management vision, mission, objectives and plans. Provides input to PV leadership and strategic direction to the local PV dept in the country/affiliate. Coaching/mentoring of the local PV dept staff employees (if applicable). Responsibilities and Accountabilities: General department Executes processes and activities in which the PV department can contribute to the compliance, efficiency and overall effectiveness of the affiliate. Responsibility for executing locally new initiatives, management tools or processes in cooperation with PV-Affiliate Management Function. Provide support in ensuring that all affiliate PV staff have access to the necessary tools and systems. Effectively collaborates with the PV-Affiliate Management Function, the affiliate functions and the competent authorities. Ensure that processes, procedures and PV files are well documented in an up-to-date and complete archive i.e. ‘audit/inspection ready’ status. Management of Product Safety Information Ensures that safety information (Adverse Events) received from all sources (e.g literature search, Market Research, Patient Support, Digital Media) by the affiliate are collected, translated and forwarded to designated Regional Global PV Headquarter, in compliance with required timelines (reporting timelines), quality guidelines and standards. Ensures that all Individual Case Safety Reports (ICSRs) are captured, tracked and managed in the applicable system(s) in accordance with applicable standards and procedures. Supports in monitoring caseload trends. Provide support for monitoring interactions with vendors that are used to conduct PV services Overseeing and monitoring compliance of case documentation Is responsible for ensuring the filing, storage and archiving of Product Safety Information in the electronic archive or paper-based archive Be aware of the system(s) in place for the handling and tracking of e.g., medical information inquiries and product quality complaints Is supporting reconciliation with other Astellas operating unit systems (e.g., Medical Information and TrackWise for Quality Assurance) and contractual partners, as applicable Supports the monitoring of vendors to which PV activities have been outsourced (If allowed by local regulations) PV Quality and Compliance Conducts assigned PV activities in alignment with regulatory requirements and internal Astellas procedures to ensure full compliance with Regulatory requirements. Supports the implementation of relevant updates to PV regulations (including maintenance reporting rules matrix), within the required timeline. Communicates any changes to PV Affiliate Management Function, EU-QPPV, the PV Regional HQ Office and/or other local business functions, as applicable. Executes PV activities in compliance with local and regional PV regulations and Astellas policies/procedures and take corrective and/or preventive actions, as appropriate and required. Supports the due diligence of potential new product acquisitions/local country licensing agreements if applicable Maintenance of PV System and Oversight Responsibilities Provides input for the PSMF regarding the affiliate communication to PV regional Head Quarters Supports in ensuring Astellas affiliate is GPvP inspection-ready: project management related to regulatory authority, business partner or internal inspections. Act as the main point of contact, and as such, coordinate regulatory authority inspections in collaboration with QA and PV: both announced and unannounced - as and when required. Supports in conducting PV self-assessments, PV audits/inspections at the affiliate and assist in developing CAPAs (with qualitative/quantitative measures and timelines) in response to findings/observations Contributes to the process of qualification of PV vendors is conducted and periodic audits are requested. Collaborates outsourced partners to ensure PV activities are conducted according to the relevant procedures Supports the establishment of contracts with Vendors and License Partners: subject to language ability. Performs activities of the Quality Management System (QMS), including QA and QC activities Supports the development and maintenance of locally applicable PV Quality documents. Ensure filing, storage and archiving of PV documentation in accordance with PV regulations and with Astellas policies and procedures. Requests to have access to, and be aware of, the affiliate business continuity plan (for example system failure and other disasters) in relation to PV activities. Responsible for ensuring a local mechanism is in place for 24/7 availability to enable appropriate handling of potential urgent safety issues by the affiliate. Contributes to the oversight and monitoring of all local studies and projects, including digital media and Astellas sponsored websites that impacts PV. Supports in the development of safety monitoring and reporting plans for clinical trials that impact the affiliate. Ensures local post-marketing programs (e.g. Post Authorization Studies [PAS], Post Authorization Programs [PAP] or market research, post marketing surveillance [PMS]) protocols are reviewed for compliance with PV requirements, as applicable. Participates in local activities concerning Risk Management Plans and Risk Minimization Measures and support the implementation activities. Provides support in ensuring local initiatives such as company sponsored websites and other digital media, registries, and marketing initiatives are reviewed for compliance with PV requirements and Astellas PV procedures. Training Provides the annual delivery, and documentation of PV Product Safety Awareness training to Affiliate (e.g., Medical Information, Sales Rep, receptionists). Also, where applicable, to third party personnel providing PV-related services, and to other staff within the territory. Supports the maintenance of local PV Training Role Matrix Quality Assurance Maintain the Quality Management System: implementation and continual improvement of QM systems, procedures, and processes, i.e.: handling of deviations, complaints and CAPAs, handling of GMP/ GDP regulated changes or escalation of potential significant quality issues. Ensure that deviations and complaints, as identified at the affiliate are raised in TrackWise and TrackWise digital, are appropriately investigated and CAPA plans are developed where appropriate. Ensure deviations, complaints, CAPAs and change control actions are progressed in a timely manner. Maintain the training system for all personnel involved in wholesale dealer and/or MAH activities and perform training of the relevant Quality Management Systems. Perform local checks following receipt of certified medicinal product according to a documented process and execute the local “Release for Distribution” for products in accordance with local regulations and guidelines. Check and prepare quality agreements with local country third parties in accordance with internal and external regulations. Perform audits of local country third parties, as appropriate. Conduct self-inspections according to the approved self-inspection plan. Ensure local GMP / GDP procedures are maintained in the Astellas Document Management Systems. Ensure that only approved Local Service Providers are used, if applicable. Collaborate with LSPs to ensure Quality Assurance requirements are followed and maintain appropriate QA oversight for GDP operations and warehouse management. Properly document changes with potential impact on GDP/GMP compliance and implement the changes in timely manner. Perform validation activities for local GDP / GMP systems, as required. Review the Product Quality Review reports in a timely manner. Support SQI investigation and recalls. Prepare for GDP/GMP Inspections by Competent Authorities and assist the Quality Assurance Lead & Responsible Person during these inspections. Prepare and respond QA Internal audits Prepare and approve monthly KPI report and submit the KPI report to the QA Sub-region lead. Required Qualifications: Minimum BA/BS (Pharmacy, Medical or Biomedical/Life Sciences preferred) preferably with an advanced professional degree Track record of demonstrable and relevant minimum 3 years’ experience within PV and/or combined PV/RA/QA; to include direct contact and engagement with national competent authorities. 1 Year people/project management experience preferred. Good understanding of establishing and maintaining (GxP) Quality Management Systems. Awareness of local industry code(s) of practice and local and/or regional PV regulations and guidelines. Experience in supporting a PV system in at least one single country; low complexity, low case volume. Awareness and experience with some aspects of a PV quality management system Proficiency in local language and business English language (written, verbal, presentation, facilitation) Show more Show less

To ensure proper receipt of packing material & misc material after proper verification of documentation, preparation of GRN. To ensure proper verification and segregation of material before preparation of GRN. To ensure material is stored as per locator codes. To ensure proper issuance of packing material from production department. To ensure proper returns of issued packing material from production department. To ensure proper maintenance of documents and records. To prepare MDN's as per SOP as & when required. To ensure day to day records of humidity / tempreture/ performance of weighing scales is being carried out and recorded. To ensure proper handling of rejected material as per SOP. To ensure proper disposal of scrap as and when rquired. To ensure timely release of packing material for production. To generate requirement of packing material and place purchase requisition as per RFC. To follow Trackwise, EDMS for change controls and revision of SOP's as and when required. To maintain the records for calibration, validation of all the equipments installed in warehouse. To reconcile all packing materials as and when required and maintain proper locator codes. Show more Show less

Position Senior Manager Sub-function Global Actions Management Function Corporate Quality Compliance Function Head Title Sr. General Manager Location: Vadodara Areas of Responsibility Ensure assessment of Regulatory inspection citations identified at Sunpharma sites to derive the global action Ensure assessment of 483s, warning letter issued to other organization by USFDA to derive the global action Ensure assessment of internal learning (such as Quality alert) to derive the global action Preparation of Global action based, following are the sub-activities: v. Review of the regulatory guidance related to the topic vi. Review of existing site practices vii. Drafting of Global action recommendations viii. Preparation of reference procedures and associated formats for Global action implementation as applicable ix. Finalization of Global action recommendation post review with Global action committee and relevant stakeholders Ensure issuance and approving of Global actions in Trackwise. Coordinating with sites for the implementation of Global action recommendations Ensure review of site action closure for completeness and correctness Ensure closure of global action upon completion of all issued site action records of a global action Ensure circulation of Global action status to relevant stakeholders Ensure compliance calls being executed as per pre-defined agenda i.e. internal and external learnings being shared and explained with stakeholders. Ensure identified gaps being shared across sites and tracked for implementation Ensure maintenance of database for regulatory inspections at SUN Pharma Review of draft response of inspection observation Ensure Sun site regulatory inspection observations trend is in place for meaningful analysis All other duties as assigned by Head Corporate Quality Compliance and CQA Travel Estimate Approximate 30% Job Requirements Educational Qualification M.SC / M. Pharm Specific Certification Not specific Skills Quality Management System, Compliance, CAPA, Investigations, Audit Management, Supplier Qualification, Change Management, Manufacturing and Engineering Assurance (OSD and Sterile) Experience Minimum 15 years Show more Show less

Job Title Manager Job Grade M2 Function Corporate Quality Compliance Sub-function Complaints Manager’s Job Title Senior Manager-1 Location: Vadodara Job Responsibilities Review of Product Quality Complaint Investigation Reports (US Market). Coordinate with other stakeholders involved in the complaint handling process. Monitor the progress of Filed Alert Reports, Recalls & Product Quality Complaint closure. Logging of Product Quality Complaints (PQC) in the database (TrackWise). Acknowledge the complaints to the complainants. Providing the response letter to the complainant. Reconciliation of received market complaints. Areas of Responsibility Product Quality Complaints Management Travel Estimate Approximately 10% Job Requirements Educational Qualification M.Sc (Life Sciences) / B.Pharm Specific Certification Nil Skills Good Technical & Communication Skills, Investigation writing, reviewing, and editing experience, candidate should have worked in USFDA work environment. Experience 13-14 years Show more Show less

Role & responsibilities 1. Prepare standard documents (SOP, batch records, specs etc) adhering to policies, procedures and regulatory requirements. 2. Responsible for sharing of periodic review reports to stake holders. 3. Responsible for carrying out all the tasks assigned by the reporting manager. 4. Expert in using Track wise digital or any Electronic Documentation Management System. 5. Responsible for carrying out admin role as per the requirement in support to stake holders. 6. Knowledge of quality systems and GMP regulations 7. Excellent verbal, organizational, written, and interpersonal skills required. 8. Sound keyboard skills and knowledge of Microsoft Office applications including Word, Outlook, Excel and PowerPoint. 9. Ability and desire to work in a team-based setting. 10. Ability to work independently and to continuously improve Quality processes. Preferred candidate profile B.Pharmacy, M.Pharmacy , M.S. degree in Chemistry, Microbiology or related field. 1 to 3 years of experience in the pharmaceutical industry (commercial manufacturing sites within API or DP), with experience in Quality Assurance. Experience of Shared Services strongly preferred (dedicated unit for the execution of specific operational tasks for the multiple business units within the organization). Strong knowledge of the pharmaceutical industry regulations applicable to API and Drug Product manufacturers. Good understanding on Good Manufacturing Practices, with practical experience on the field. Expert in using Track wise digital or any Electronic Documentation Management System

Role & responsibilities 1. To ensure GMP compliance on shop floor. 2. To follow SOPS and policies and perform tasks as per the SOP. 3. To perform investigation along with CFT to identify the root cause. 4. To participate in the preparation and review of investigation report for OOS, OOT, product quality complaints and unplanned deviations related to manufacturing. 5. To initiate change controls, planned deviations and unplanned deviations related to production department. 6. To provide the awareness training and SOP related trainings to concern personnel. 7. To develop skills in subordinates by motivation and on the job training. 8. To coordinate with internal and external auditor along with CFT. 9. Drafting of investigation for OOS, OOT, product quality complaints and unplanned deviations related to manufacturing. To prepare review and timely compliance of audit related observations of production department . Preferred candidate profile B.Pharma / M.Pharma candidate having regulatory exposure of handling QMS systems in pharma industry and sound knowledge technical knowledge as well as good communication skills. candidate must possess 5 to 10 yrs experience in handling QMS process and must have worked in the past in Quality/Manufacturing function.

Primary Function of Position The EQMS Business Analyst will be responsible for identifying, developing and implementing software solutions. This will include working with process owners to identify continuous improvement opportunities and develop software solutions to support process effectiveness and efficiencies. Individual will also be accountable for managing projects and software throughout their respective lifecycles. Essential Job Duties Directly participate in the analysis, configuration, modifying and implementation of IT Business Systems Demonstrate good communication, analytical and problem-solving skills to help identify, communicate and resolve system issues in order to maximize the benefit of IT systems Analyze the effectiveness and efficiency of existing business processes and business requests, and recommend solutions using system standards and best practices Conduct analysis of system specifications, configurations and develop appropriate documentation Create detailed specifications and process flows to provide direction to application developers Perform solution designing, requirements definition, functional design, testing and implementation of IT solutions Support, assist and train the users on new modified system configurations highlighting the impact on business processes Maintain IT Business system integrity and application notes, system upgrades, changes, and user updates Work closely with onsite team, off shore team, managers and executives to ensure the release of high quality solutions Comply with regulatory and change control requirements and processes #LI-Hybrid Qualification Required Skills and Experience Minimum 5 years of TrackWise System Analysis experience Experience in Medical Device manufacturing industry and systems regulations (21 CFR Part 11, GxP, GAMP, etc.) and good understanding of CAPA and Complaints processes Perform business requirements gathering, requirements analysis, business system design, installation, configuration, user testing and validation support of TrackWise based applications. Java Programming: Strong knowledge and experience in Java programming, including Java 8 features and beyond. Frameworks: Proficiency in Java frameworks such as Spring, Hibernate, and Apache Struts for building and maintaining applications. Web Technologies: Understanding of web technologies like HTML, CSS, and JavaScript, along with frameworks like Angular or React. Database Management: Experience with database management systems (DBMS) like MySQL, Oracle, or MongoDB, including SQL queries and database design Create workflows, Business rules, TWC automation, Notifications and Migrate updates. Create TrackWise WebServices(Search/Populate/Transfer) using OWS/IWS. Create and Implement Crystal Reports Exposure to integration with SAP ERP and CRM systems preferred Familiarity with Software Development Lifecycle (SDLC) processes Good verbal and written communication skills Ability to work on multiple projects concurrently. Ability to work with minimum supervision or guidance Should contribute in team building measures like Knowledge Management & Mentoring Required Education and Training Minimum education: Bachelor's or undergraduate degree in Computer Science, Information Systems or equivalent experience Preferred Skills and Experience Trackwise & Trackwise Digital experience preferred Additional Information ${jobpostDetails.jobAd.sections.additionalInformation.text }

Greetings from HCL! Currently Hiring for "Trackwise Digital" Experience - 5-14 years Location - Bangalore / Chennai / Noida / Pune / Hyderabad Notice period - Immediate to 30 days Only CTC - Can be discussed Interested candidate please share below details along with update resume Name- contact Number- Email ID- Total Experience- Relevant Experience- Current company- Preferred location- Notice Period- Current CTC- Expected CTC- Interested candidate please drop mail to "kushmathattanda.baby@hcltech.com" Regards, Kushma kushmathattanda.baby@hcltech.com

Role & responsibilities 1. Shall have an exposure to SRA inspections like USFDA, EU, TGA etc. 2. Should have experience of implementation and handling and troubleshooting any of QAMS software like Trackwise /calibre(DMS, QMS), nichleone(TMS), LIMS,SAP etc. 3. Should have experience of handling QAMS notifications like change control, deviation, OOS, incidents, risk assessment, market complaint, etc. 4. Should have an experience of MRM/ IPQA / participation in internal. Preferred candidate profile B. Pharm/M. Pharm with 4+yrs of experience in implementation of QAMS software, LIMS, SAP, nichleone.

Role & responsibilities 1) To perform the analysis by following cGMP, GLP, ALCO+, and safety compliance 2) To perform the sampling, testing of RM, PM, In-process, Intermediate and Finished product. 3) Participate in Investigation of deviation, Incident, OOS etc. 4) To perform all qualification activities of instrument and equipment in QC Lab. 5) Aware of calibration and operation procedure for instruments ( balance, K.F, GC. UV,refratometer and viscometer etc,) 6) Experience of QC software like Tiamo 3.0, Lab solution, SCM etc. 7) Preparation of documents ( SOP, protocol etc) related to Quality control.