869 Lims Jobs - Page 22

Head Quality, Sterlite Copper Be a part of the world’s leading natural resources conglomerate Exciting transformational opportunity and chance to make a difference Location: Silvassa Vedanta, a future-focused and growth-oriented company is a fully integrated producer of Oil & Gas, Zinc - Lead - Silver, Aluminium, Power, Iron Ore & Steel, Copper, Nickel, Cobalt, Ferrochrome and Manganese, with a fast-growing metal recycling capacity, and a broad range of critical minerals. We are a dominant player in power generation, transmission, renewable energy solutions, optical fibre, display glass and soon semiconductors. With our world class, low-cost and long-life assets, Vedanta contributes 1.4% towards India’s GDP. Sterlite Copper, a Unit of Vedanta Ltd., is a leading copper and nickel producer in India with units at Tuticorin, Silvassa and Goa in India, Fujairah Gold in UAE. Since its inception in 1996, Sterlite Copper had steadily grown to become a leading copper producer contributing up to 40% of India’s demand for refined copper. The company is rapidly scaling its efforts to become a Global Leader in Copper Production, offering a range of high-quality Copper products. With KCM - Zambia, Vedanta has become a fully integrated producer of copper and shall cater to fast-growing demand. Through its initiative “Sterlite Cares” Sterlite is committed to highest standards of governance and responsible environmental practices for sustainable development. Sterlite Copper is a winner of several global and national accolades for its Business, Operations, HR, Energy and water conservation, sustainability and CSR. The Opportunity: An exceptional career opportunity for innovative, committed, and forward-looking individual to create transformational value in Quality function. The ideal incumbent will be responsible for overseeing quality assurance activities in the copper manufacturing plant, including the refinery, anode casting, and rod plant, ensures products meet quality and compliance standards. This involves developing and implementing quality protocols and procedures, inspecting and testing raw materials, in-process products, and finished goods, and having knowledge of assay exchange. The leader will also be leading continuous improvement initiatives and benchmarking to enhance product quality, reduce waste, and improve processes is crucial, along with ensuring compliance with industry standards, regulations, and certifications, and promoting a safe work environment. Managing and mentoring the quality assurance team, providing guidance, resolving quality issues, conducting root cause analysis, and implementing corrective actions are key responsibilities. Collaboration with production teams and suppliers is essential. Driving innovation by implementing new technologies and methodologies related to LIMS, automation, and product development, adhering to ESG standards, promoting sustainable practices, and reducing environmental impact, while maintaining compliance with safety, environmental, and regulatory requirements, are also critical aspects of the role. The Successful Applicant Bachelor’s degree in chemistry or chemical engineering with a minimum of 15 years of experience in quality assurance within a manufacturing environment, preferably in the copper industry. Strong knowledge of quality assurance principles, practices, and standards specific to copper manufacturing, Assay Exchange and Quality Audit standards and certifications with proven experience in analyzing copper products and providing actionable insights. Excellent analytical and problem-solving skills, strong leadership and team management abilities, and excellent communication and interpersonal skills. Proven leadership in driving cross-functional teams, data analysis, and innovation in digitalization efforts are required attributes for this role. What we’ll offer you: Outstanding remuneration and best in class rewards Opportunity to be with a globally benchmarked organization with best in class-facilities and people practices Fast track career growth Everything we do is shaped by the Vedanta Values of Trust, Entrepreneurship, Innovation, Excellence, Integrity, Care and Respect. We are an equal opportunity employer and value diversity at our company and are proud of our best-in-class people practices. If this sounds like you and the opportunity you are looking for, apply now and be a part of our exciting growth journey. Show more Show less

Job Description Labware 7. LIMS implementation, Master data creation, Validation. Caluculation configurations. CSV documentations, Test Script review, Instrument integrations. LIMS trouble shooting and resolutions. QAMS activities, CCP, CAPA, Deviation investigation. Work Experience 4-7 years of experience in QC and LIMS Implementation Education Post Graduation in Analytical Chemistry or Analytical Chemistry Graduation in Pharmacy or Pharmacy Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence

Key Responsibilities: Oversee Daily Operations: Manage the daily operations of the food testing laboratory, ensuring timely and accurate testing of food products in compliance with client requirements, regulatory standards, and lab procedures. Quality Control & Assurance: Establish, implement, and maintain robust quality control procedures to ensure the precision, accuracy, and reliability of test results. Oversee the implementation of ISO/IEC 17025 quality systems and drive continuous improvement initiatives to enhance laboratory performance. Manage the planning and successful execution of proficiency tests to maintain high standards of quality assurance. Techno-Commercial Integration: Combine technical expertise in food science with business acumen to drive growth and profitability. Support business development efforts by providing innovative solutions to clients, ensuring they receive optimal testing services that meet both their needs and industry standards. P&L & Budget Oversight: Take full responsibility for the lab's profit and loss (P&L), including overseeing the lab’s budget, managing operational expenses, and optimizing resource allocation. Identify and capitalize on opportunities to increase revenue, such as expanding service offerings, improving operational efficiency, and enhancing customer satisfaction. Compliance & Regulatory Adherence: Ensure the laboratory complies with relevant industry standards, regulatory requirements, and accreditation criteria (such as ISO/IEC 17025 or other local standards). Maintain and manage necessary certifications, ensuring the laboratory adheres to all regulatory guidelines required by clients and governing bodies. Qualification & Experience Master’s degree in food science / Chemistry. 20+ years of proven experience in a food laboratory environment with a focus on technical operations and governance. Experience on laboratory NABL accreditation ISO–17025:2017 and other food governing agency recognitions viz., APEDA, EIC, FSSAI, BIS and AGMARK. Technical Skills and Other Expertise Demonstrate strong interpersonal, learning, and organizational skills, enabling effective collaboration with diverse teams / stakeholders, while adeptly managing stress, time, and people. Expertise and hands on experience of laboratory : conventional and Instrumental analysis. Excellent analytical skills and ability to interpret data to drive decision-making and process improvements. Team, Lab and Cost Management. Internal & External Audit. Pesticide Residue Analysis (PRA) Familiarity with laboratory information management systems (LIMS) and other relevant software Show more Show less

JD Responsibilities: Develop and implement custom configurations to tailor the LabWare LIMS system to specific laboratory workflows and requirements. Integrate laboratory instruments with the LabWare LIMS system to automate data collection and enhance efficiency. Manage and update static data within the LabWare LIMS system to maintain accuracy and consistency. Demonstrated experience in integrating Chromeleon software with LabWare LIMS for seamless data management. Knowledge of integrating and managing Empower software within the LabWare LIMS environment. Proficiency in using SAP Crystal Reports for generating and customizing reports. Experience in managing and integrating ELN with LabWare LIMS for structured documentation of experiments. Proven experience in managing projects including design, coding, unit testing, and implementation of LabWare LIMS. Develop detailed test cases and execute test scripts to ensure the system meets user requirements and functions correctly. Provide ongoing support for the LabWare LIMS system, ensuring it meets laboratory needs and complies with regulatory standards. Collaborate with laboratory staff, scientists, and other stakeholders to understand their requirements and translate them into system specifications. Strong understanding of current Good Manufacturing Practices (cGMPs) and regulatory compliance requirements. Show more Show less

JD - We are seeking a skilled and motivated BIOVIA LIMS Application Support Specialist to join our team. The successful candidate will be responsible for providing technical support, troubleshooting, and maintenance for the BIOVIA Laboratory Information Management System (LIMS) . This role requires a strong understanding of laboratory workflows, data management, and the ability to work closely with end users to ensure optimal system performance. Key Responsibilities: Provide technical support and troubleshooting for BIOVIA LIMS applications. Assist in the configuration, customization, and ongoing maintenance of the LIMS system. Collaborate with laboratory staff to understand user needs and deliver solutions to enhance system functionality. Conduct user training sessions and develop documentation on system usage and best practices. Monitor system performance and apply necessary updates and patches. Coordinate with the IT team to ensure seamless integration with other laboratory software and hardware. Contribute to the development and implementation of new LIMS features and enhancements. Maintain detailed records of support activities and user interactions. Qualifications: Bachelor’s degree in Computer Science, Information Technology, Life Sciences, or a related field. Minimum of 4 years of experience in LIMS application support or a similar role. Strong knowledge of BIOVIA LIMS and related applications. Familiarity with laboratory workflows and data management practices. Excellent problem-solving and analytical skills. Strong communication and interpersonal abilities. Ability to work independently as well as collaboratively within a team. Experience with SQL, scripting languages, and system integration is a plus Show more Show less

Job Summary (ISG) We are seeking a skilled Analyst with 3 to 8 years of experience in Validation and Testing in Labware LIMS Labvantage LIMS GLIMS CDS and any Lab Systems. Responsibilities Experience/ exposure to US FDA 21 CFR Part 11 EU Annex 11 and GAMP 5. Experience in testing and knowledge in any one of the Lab systems (LIMS CDS SDMS etc) is must. Should worked in pharmaceutical domain and its related knowledge is must Good communication and technical writing skills are a must Developing validation documentation for pharmaceutical equipment facilities and computerized systems used in GLP GMP and GCP environments. Project Deliverables will encompass specifications test protocols and standard operation procedures and systems may include Process Automation Laboratory Automation Enterprise IT Applications and Network Infrastructure. Prepare and execute TP IQ OQ PQ TSR Traceability Matrix FRA Exposure to Regulatory Audits Using previous use cases and best practice counsel on highly regulated environments Knowledge on working in Jira HP ALM or any automation testing tools Certifications Required Certified LIMS Administrator Labware LIMS Certification Labvantage LIMS Certification Show more Show less

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

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

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

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

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

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

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

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

Company Overview: One Vector is a rapidly growing IT professional services startup specializing in AI/ML, Data Science, Analytics, IT Quality/Compliance, and Pharmacovigilance for biotech companies. Our mission is to empower biotech organizations with cutting-edge solutions and expert insights to drive their success. As we continue our rapid expansion, we are seeking a dynamic and experienced Computer System Validation (CSV) Specialist to join our team. Position Overview: We are seeking a highly skilled and motivated Software Validation Engineer professional to lead and support the validation lifecycle of GxP regulated computerized systems. In this client-facing role, the ideal candidate will have a strong background in computer systems validation (CSV), quality systems, and Software Development Life Cycle (SDLC) principles. This role is pivotal in maintaining the integrity, reliability, and compliance of digital systems supporting manufacturing, laboratory, and business functions for our clients. This candidate will act as a trusted advisor to our clients, guiding them through the complexities of regulatory compliance while also ensuring the effective implementation and ongoing management of their computerized systems and Lifecycle procedures with Data Integrity requirements. Exceptional communication skills and the ability to forge strong relationships with clients are essential for this role. The successful candidate will be strategic, results-oriented, and committed to driving the company's growth in the biotech sector. Key Responsibilities: Lead validation activities across the full lifecycle of GxP systems including planning, testing, deployment, and periodic review. Develop and review validation deliverables such as Validation Plans (VP), User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Traceability Matrices (RTM), Test Protocols (IQ/OQ/PQ), Validation Reports (VR), and DM (Data Migration) Protocol & Scripts. Oversee vendor qualification assessments and documentation reviews and approvals to ensure third-party systems align with client validation expectations and regulatory standards. Guide clients through the validation process to ensure compliance with regulatory standards such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 Conduct risk assessments for computerized systems to identify potential gaps in compliance. Review and identify validation deviations and resolve deviations with appropriate corrective/ preventive actions Develop validation strategy and documentation for cloud-based and SaaS GxP systems, ensuring alignment with client IT controls, cybersecurity policies, and data residency requirements. Provide Quality Review and Assessment of associated change requests related to processes, IT infrastructure, equipment and computer systems. Manage project governance, including providing progress updates of the assigned deliverables, driving timely closures of escalations and facilitating strategic decisions with senior management. Provide recommendations for mitigating risks related to data integrity, security, and system functionality. Develop Standard Operating Procedures (SOPs) and work instructions for clients to support ongoing system use and compliance. Stay updated on regulatory changes in the life sciences industry and advise clients on how these changes impact their QMS software validation efforts. Provide guidance on data integrity principles and ensure alignment with industry standards. Responsible for other duties and projects assigned Qualifications: Required: Bachelor's degree in engineering or scientific discipline. IT Quality Assurance professional with a minimum of 9 years of experience with computerized system validation in Life Sciences industry. Experience validating systems such as LIMS, MES, ERP, QMS, or other laboratory/manufacturing software. Proficiency in authoring, reviewing and executing computer validation documentation (URS, VP, Specification documents, FRA, IQ, OQ, PQ, RTM, VSR). Proven track record of working with regulatory and industry frameworks such as FDA 21 CFR Part 11, EU Annex 11, GAMP 5, SDLC. Ability to work independently and collaboratively across cross-functional teams. Familiarity with audit readiness and experience supporting regulatory inspections or internal audits. Preferred: Master’s degree in a relevant discipline. Experience with QMS software implementation is highly desirable. Experience working with SaaS systems, data integrity programs, and GxP cloud validation strategies. Familiarity and/or industry certification with tools like ARISg database, QMS software platforms such as MasterControl, Veeva Vault QualityDocs/Quality Suite/Safety, paperless validation tools (Kneat, ValGenesis, or similar). Experience of working for US/EU based clients is a plus Show more Show less

India - Hyderabad JOB ID: R-217412 ADDITIONAL LOCATIONS: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Jun. 13, 2025 CATEGORY: Information Systems Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Manager Software Engineering - Biological Studies What you will do Let’s do this. Let’s change the world. In this vital role you will primarily focus on designing, developing, and maintaining software solutions for Research scientists. Additionally, it involves automating operations, monitoring system health, and responding to incidents to minimize downtime. You will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements scientific software platforms such as Laboratory Information Management Systems (LIMS) that enable the capture of lab workflows & experimental data and Electronic Lab Notebooks (ELN) that act as Amgen’s System of Record ensuring data integrity and business continuity. The ideal candidate possesses experience in the pharmaceutical or biotech industry, strong technical skills, and full stack software engineering experience (spanning SQL, back-end, front-end web technologies, automated testing). You will play a pivotal role in shaping the software ecosystem, ensuring that it meets both current and future business needs. Roles & Responsibilities: Lead, mentor, and grow a high-performing team of software engineers. Foster a culture of innovation, collaboration, and continuous learning. Take ownership of complex software projects from conception to deployment Manage software delivery scope, risk, and timeline Possesses strong rapid prototyping skills and can quickly translate concepts into working code Contribute to both front-end and back-end development using cloud technology Develop innovative solution using generative AI technologies Conduct code reviews to ensure code quality and adherence to best practices Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations Identify and resolve technical challenges effectively Stay updated with the latest trends and advancements Work closely with product team, business team including scientists, and other stakeholders Design, develop, and implement applications and modules, including custom reports, interfaces, and enhancements Analyze and understand the functional and technical requirements of applications, solutions and systems and translate them into software architecture and design specifications Develop and execute unit tests, integration tests, and other testing strategies to ensure the quality of the software Identify and resolve software bugs and performance issues Work closely with cross-functional teams, including product management, design, and QA, to deliver high-quality software on time Maintain detailed documentation of software designs, code, and development processes Customize modules to meet specific business requirements Work on integrating with other systems and platforms to ensure seamless data flow and functionality Provide ongoing support and maintenance for applications, ensuring that they operate smoothly and efficiently What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications and Experience: Master’s degree with 4 - 6 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Bachelor’s degree with 6 - 8 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Diploma with 10 - 12 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field Preferred Qualifications and Experience: 2+ years of experience in managing technical teams 3+ years of experience in implementing and supporting biopharma scientific software platforms Proficient in a General Purpose High Level Languages (e.g. Python, Java, C#.NET) Proficient in a JavaScript UI Framework (e.g. React, ExtJs) Proficient with SQL (e.g. Oracle, PostgreSQL, Databricks) Experience with event-based architecture (e.g. Mulesoft, AWS EventBridge, AWS Kinesis, Kafka) Good-to-Have Skills: Strong understanding of software development methodologies, mainly Agile and Scrum Hands-on experience with Full Stack software development Strong understanding of cloud platforms (e.g AWS) and containerization technologies (e.g., Docker, Kubernetes) Working experience with DevOps practices and CI/CD pipelines Experience with big data technologies (e.g., Spark, Databricks) Experience with API integration, serverless, microservices architecture (e.g. Mulesoft, AWS Kafka) Experience with monitoring and logging tools (e.g., Prometheus, Grafana, Splunk) Experience of infrastructure as code (IaC) tools (Terraform, CloudFormation) Experience with version control systems like Git Experience with automated testing tools and frameworks Experience with Benchling, Revvity, IDBS, or similar LIMS/ELN platforms Professional Certifications: AWS Certified Cloud Practitioner or Solutions Architect Soft Skills: Excellent problem solving, analytical, and troubleshooting skills Strong communication and interpersonal skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to learn quickly & work independently Team-oriented, with a focus on achieving team goals Ability to manage multiple priorities successfully Strong presentation and public speaking skills What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Primary skills:Technology->Life Sciences->LIMS Experience in developing instrument drivers using SDMS/Talend/Java is to have. At least 5 years of experience in software development life cycle. At least 5 years of experience in Project life cycle activities on development and maintenance projects. At least 5 years of experience in Design and architecture review. Good understanding of sample management domain and exposure to life sciences projects Ability to work in team in diverse/ multiple stakeholder environment Analytical skills Very Good Communication skills At least 4-8 years of experience in LIMS(LV/LW) – Implementation /Configuration/Customization using Java, Java script. integration with Lab applications, and should have implemented at least 2-3 projects with role involving development using LabVantage platform and Jasper/iReport/Java reporting tool Interface with key stakeholders and apply your technical proficiency across different stages of the Software Development Life Cycle including Requirements Elicitation and translating to functional and/or design documentation for LabVantage LIMS solution, Application Architecture definition and Design, Development, Validation and release. Ability to develop value-creating strategies and models that enable clients to innovate, drive growth and increase their business profitability Good knowledge on software configuration management systems Awareness of latest technologies and Industry trends Logical thinking and problem solving skills along with an ability to collaborate Understanding of the financial processes for various types of projects and the various pricing models available Ability to assess the current processes, identify improvement areas and suggest the technology solutions One or two industry domain knowledge Client Interfacing skills Project and Team management Show more Show less

Overview: THE ROLE: The Staff Application Analyst will work within Agile Systems and Operations team to provide applications, business process support and continuous process improvement related to Oracle Product Lifecycle Management. This position is responsible for business process analysis, technical solution development, implementation, training and maintenance of the Agile PLM, Oracle fusion PLM Cloud, and related systems and applications. The Staff Application Analyst will work with various business groups and users in defining, prioritizing, and executing process, application enhancements and projects. In addition, the position will play the critical role of ensuring that users have adequate clarification and support on all business functional, technical requirements and specifications related to applications. HOW YOU WOULD CONTRIBUTE: Evaluate business processes and system capabilities and develop requirements for enhancements along with business collaborators. Develop and implement sound solutions related to Agile PLM and Oracle PLM Cloud. Evaluate and implement modern technology including Agile PLM, PLM Cloud application configurations, process extensions, workflow modifications, and security. Develop Agile-application-based solutions to support various enterprise application integrations including Oracle EBS, Oracle Agile for Process (Oracle P4P) Systems, LIMS (Laboratory Information System) and other related applications. Provide support to global business users to ensure the optimal performance of processes and system use. Participate in Change Management activities. Produce documentation and training on related business processes including application validation documents. Interact with Oracle Cloud Services on routine application services, issue resolutions and system upgrades. Provide daily/weekly/monthly updates to management staffs. WHAT’S SPECIAL ABOUT THE TEAM: Agile PLM India team supports globally for production support , project development and enhancements. Team is bunch of experts with great experience and attitude. We work as a team supporting each other and believe in continuous learning. SKILLS AND BACKGROUND REQUIRED TO BE SUCCESSFUL: Skills Working experiences and skills with Oracle PLM Cloud, Agile 9.3.X (preferred 9.3.4) SDK/PX, J2EE technologies including Core JAVA, JSP, Servlet, JDBC, HTML, JavaScript, Groovy Scripting, XML. Linux/Unix, Weblogic, Windows servers, Web portal technologies, SQL. Good communication, interpersonal and documentation skills Business process analysis and design Excellent problem-solving skills and the ability to analyze complex business requirements. Experience: Minimum 3 plus years of development experience with Agile 9.3.X (preferred 9.3.4) SDK/PX, JSP, Servlet, JDBC, HTML, JavaScript, Groovy Scripting, XML. Linux/Unix, Weblogic, Windows servers, SQL. Minimum a year of hands-on and relevant experience in Oracle Cloud PLM Product Development, Product Data Hub (PDH), Product Master Data Management, Quality Management, and Innovation Management Implementation knowlege of Oracle's Cloud PLM suite of features Experience with Oracle PLM Cloud integration capabilities such as Oracle Integration Cloud (OIC) In-depth experience with Agile PLM APIs and web services using REST and SOAP Knowledge of Oracle Product Life Cycle Analytics (OPLA), Oracle Business Intelligence Suite (OBIEE) technology platforms. Experience with supporting Agile PLM systems integration using SCMnet adaptors, Web Services, or an equivalent middleware. Good working knowledge of Agile tools like Data Load, ACP and Agile PLM Configurations for various modules including PC, PPM, PQM, PCM. Experience with product development process, data conversion and data migration. Education: Bachelor’s degree in engineering, science, or information technology PREFERRED QUALIFICATIONS: Good knowledge, and skills working with business and agile users on requirements gathering, scoping analysis and solutions. Good and solid background and experiences with life sciences industry, compliances, regulatory, 21 CFR Part 11 validation processes and documentations. Certification of Oracle PLM Cloud, MDM, and PDH or equivalent experience is desired. Experienced and knowledgeable in PLM product, product functionality and related family of products Understanding of solutions, business processes, or technology designs within a product/technology family Oracle Transactional Business Intelligence (OTBI) and Business Intelligence Cloud Connector (BICC) skills

JOB OBJECTIVE Manages the day to day operation of the plant laboratory. Responsible for managing all aspects of the laboratory including people, equipment , budgets, IT, Regulatory complainces, etc. support systems, etc. Provides analytical support to CPS pune plant mainly and operating units within the region including Group, Division, and Bottlers. Ensures all the analytical testing programs are executed in accordance with Company requirements. KEY RESPONSIBILITY AREAS 1Develop and execute people plans for the Laboratory: Create vision for the lab , align global labs Strategy. Establish performance objectives, personal development plans, evaluate resource requirements, reallocate resources to meet testing needs, reward and recognition program. Work with QSE manager and Plant Manager to identify growth opportunities across the analytical network.Think proacively and find out efficient way of working which can bring savings and/or higher efficiencies in testing/release Expense and Budget Management: Manage expenses for laboratory including creation of annual operating budget and required capital plan. Monitor rolling estimates for lab and adjust spending accordingly. Evaluate asset utilization and take decisions to improve return on investment. Operating Efficiency: Ensure laboratory is operated under local and TCCC safety requirements. Constantly review and evaluate risks and exposures and adjust chemical hygiene plan accordingly. Drive focus of laboratory from traditional testing facility to full service provider. This will also include innovative and automated/digital way of testing. Engage IQD, CPS global, OU, Bottlers and Corporate in determining analytical priorities. Develop associates to SME status in support of key focus groups e.g. New lab Strategy,LIMS, PBT,SLE,etc. Should have expertise in handling advance analytical instrumnets like GC, LC, Mass Spectrometry, ICP, IC, AA, IR, FTNIR, and Microbiology. Should be able to trouble shoot equipment breakdown and provide direction to analyst to ressolve any testiung or equipmnet related iussues. Should be familiar with testing of food grade ingredinets, beverages, juice , Water, waste water, etc. as well. Evaluate and analyse analytical risk and priorities by product and supplier and assesses current capability and future needs to support business within the area. Evaluate risks and trends associated with analytical support/ data and adjusts testing programs accordingly Work with IMCR manager and core team members in the creation of a knowledge management unit, defined to support Divisions and Bottlers in understanding ramifications and actions needed to address test results and to react to adverse incidents / IMCR issues. Drive accreditation process in lab, including determination of accreditations needed, identification of resources to support initiative, motivation of associates etc. Identify and implement the need for accreditation throughout lab. He should be well versed with FSSAI testing, BIS,WHO, FDA and various phamacoepial testing requirements and methods. Consult with LT, Internal functions and Corporate on service performance and identifies opportunities to improve support to TCCC system. Develop strategic plan for third party laboratories within geographical region including identification, selection and monitoring of performance. Work with leadership team to identify performance monitoring needs such as proficiency programs, and determines performance metrics/ dashboard to examine overall lab performance. Work as part of CPS QSE network team to define and enhance testing programs and solutions. JOB SPECIFIC COMPETENCIES Develops and Inspires Others, Building positive working relationships , Delivers Results , Gaining commitment, Continuous Improvement, Decision Making, Balances Immediate and Long-Term Priorities , Strategic Thinking, Resource Planning / Utilization, Project Management, Change Management, Lives the Values. Expertise in: - Laboratory Information Systems Advance analytical methods (GC/LC/ICP/MS/IC,IR, etc) SAP S4 HANA Proficiencieny in: - Implementation of KORE, FSSAI and ISO Requirements - Ability to coach and train others in effective lab management Influencing others Method development and validation EDUCATIONAL QUALIFICATION : ESSENTIAL: MSc in Chemistry or related field. Hard core analytical chemist with indepth testing knowledge, data interpritation, validations, digital way of working and lab information management. DESIRED: certified in accordance with a Global Analytical Organization such as AOAC. Desired Six Sigma Green Belt, Project Management, Leadership training,Advance testing instrument operation and trouble shooting, people management skills. MINIMUM RELEVANT EXPERIENCE REQUIRED: 12-15 years experience of leading laboratory testing and decision making of food or pharmaceutical industry. Should have experience in analytical processes such as GC, LC, Mass Spectrometry, ICP, IC, AA, IR, FTNIR, and Microbiology. Should be able to trouble shoot equipment breakdown and provide direction to analyst to ressolve any testiung or equipmnet related iussues. Should be exposed to ingredinet and FG testing of beverage bases. Should be familiar with juice testing, ETP and Water tetsing as well. Should be familiar with accreditation and certification programs such as ISO17025, 9001, 14001, 45001, 22000,KORE. Skills Six Sigma; Waterfall Model; Troubleshooting; Microsoft Office; ISO 18000; ISO 14000 Annual Incentive Reference Value Percentage:15 Annual Incentive reference value is a market-based competitive value for your role. It falls in the middle of the range for your role, indicating performance at target.

Job description :- Instrumental Analysis: Perform routine and stability analysis of raw materials, intermediates, and finished products using HPLC, UV-Vis Spectrophotometer, FTIR , etc. Operate and calibrate analytical instruments as per SOPs and regulatory guidelines. Troubleshoot HPLC and other lab equipment in coordination with service engineers when required. Documentation & Compliance: Prepare and maintain analytical reports, test data sheets, protocols, and logs as per GDP (Good Documentation Practices). Ensure all QC activities comply with cGMP, GLP, and other regulatory guidelines . Assist in investigation and documentation of OOS, OOT, and deviations . Sample Handling & Testing: Receive and analyze raw material, packaging material, in-process samples, and finished goods as per approved specifications. Maintain proper sample disposal records. SOP & Record Management: Review and update Standard Operating Procedures (SOPs), specifications, and analytical methods. Maintain laboratory notebooks, logbooks, equipment usage logs, and calibration records accurately. Equipment Handling & Calibration: Operate and maintain lab instruments including HPLC, Dissolution Test Apparatus, pH meter, Analytical Balance, etc. Conduct periodic calibration and qualification of instruments. Audit Readiness: Prepare and support internal and external audits (e.g., USFDA, WHO, MHRA). Maintain complete and audit-ready documentation at all times. Key Skills & Competencies: Hands-on experience in HPLC analysis and troubleshooting . Strong understanding of analytical chemistry, GMP, GLP , and ICH guidelines . Attention to detail, data integrity, and documentation accuracy. Good communication and team coordination skills. Proficiency in MS Office and LIMS (preferred). Qualifications: B.Pharm / M.Pharm / M.Sc / B.Sc (Chemistry or related field) Minimum 2–5 years of experience in QC in a regulated pharmaceutical environment . Additional Requirements: Willingness to work in shifts (if applicable). Sound knowledge of safety protocols and laboratory hygiene . Good analytical and problem-solving abilities. Familiarity with regulatory audits and compliance standards . Job Types: Full-time, Permanent Pay: ₹18,000.00 - ₹25,000.00 per month Benefits: Cell phone reimbursement Health insurance Paid sick time Provident Fund Schedule: Day shift Supplemental Pay: Joining bonus Performance bonus Yearly bonus Work Location: In person Expected Start Date: 01/07/2025

Experience - 1-5years Location - Hyderabad Notice Period - Immediate to 15 days Key Responsibilities: Manage user accounts, roles, and permissions within Revvity E-Notebook. Configure templates, workflows, and metadata fields to align with lab processes. Provide training and support to users; develop SOPs and user documentation. Ensure compliance with data integrity standards (e.g., ALCOA+, 21 CFR Part 11). Troubleshoot system issues and coordinate with IT and vendor support. Maintain documentation of system configurations, user logs, and change history. Support audits and inspections by providing system access logs and compliance reports. Technical Requirements: ELN Experience: Hands-on experience with Revvity E-Notebook or similar platforms (e.g., LabArchives, Benchling, IDBS). System Configuration: Ability to configure templates, workflows, and user roles. SQL & Oracle: Proficiency in writing SQL queries for data extraction, reporting, and troubleshooting; experience with Oracle databases for backend data management and integration. Data Management: Understanding of structured data entry, metadata tagging, and version control. Compliance Knowledge: Familiarity with GxP, 21 CFR Part 11, and audit trail requirements. Basic Scripting (Preferred): Exposure to scripting languages (e.g., Python, JavaScript) for automation or integration tasks. API Integration (Preferred): Understanding of REST APIs for connecting ELN with LIMS or other lab systems. IT Collaboration: Ability to work with IT teams on system upgrades, backups, and security protocols. Documentation Tools: Proficiency in Microsoft Office, SharePoint, and documentation platforms like Confluence or Notion. Soft Skills: Good communication and interpersonal skills. Ability to work independently and in cross-functional teams. Show more Show less

Title: Digital Product Owner QC & HSE Location: Hyderabad Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally . Our mission is to bring health in people’s hands by making self-care as simple as it should be . For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands , our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets , we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com. The Digital Product Owner QC and HSE is responsible for managing the Quality Operations solution portfolio within our Manufacturing Plants, roadmap and projects globally; this currently mainly includes Quality Management solution (QMS based on Veeva Technology), Laboratory Integrated Management system (LIMS), Laboratory Acquisition system (LAS) and the integration layer with the existing and future solutions within the digital framework at site level (i.e. Manufacturing ERP, Equipment’s, Analytics solutions). One of the primary missions will be securing the build, delivery and future maintenance of the LIMS program that aims to transform and standardize the Quality processes and application across all the Laboratories in sites and R&D centers. This program is expected to start in 2025 and will last for the next 2-3 years. In the transformation, he/she will play a key role interacting with others areas to secure Opella´s full autonomy on Quality and HSE domains As a member of the Global Digital M&S Team, He/She will work closely with: the Opella M&S Innovation Solutions and Operational Excellence teams, Digital Quality Solution Architect Lead, Quality teams and our Master Data organization to ensure that we are clearly identifying business/site needs, prioritizing features, guiding the work and developing the vision and roadmap Digital Business leaders, the role drives the overall awareness, prioritization, and orchestration of resources (budget and manpower) to deliver a workable product on the Quality Operations and Product management space that brings business value External Partners (i.e Consulting Companies, Vendors) to track the deliverables agreed as part of the transformation/separation project (Butterfly) This position will require leadership, motivational and collaborative skills to continually drive Quality and Product Management solutions while executing in a POD/Agile operating model. He/She will require deep working knowledge of existing technologies and solutions (i.e. QMS Veeva, SAP, Salesforce, Thermofisher, etc) with the ability to understand solutions being proposed and how existing solutions can be adapted to match evolving Quality operations and product data needs. He/She will actively manage business expectations and proactively work on closing any gaps while ensuring strategic principles are maintained. Businesses scope: Quality Assurance, Quality Control, HSE, Product Lifecycle Management - sites (13) and ALL Markets were Opella has presence. Key Accountabilities (included But Not Limited) Defines and owns end-to-end Quality and Product Management solution Roadmap in alignment with business stakeholders, Quality Solution Architect and Butterfly Project. Fully accountable on the delivery of the Quality / Product Management roadmap and all related management activities (i.e. budget, resources, performance) with special attention on strategic programs (i.e. QMS roll out and Product Data solution) Responsible for the set up and execution of the POD/Agile operating model of the Quality Management Product Line and Product Management Product Line. Supports overall Quality and Product Management analytics transformation journey Tracks comprehensive metrics to evaluate the effectiveness and efficiency of Quality Management products for Opella to deliver value Understand Opella business requirements (including analytics ones) for the various processes in the Quality and Product Management domain, ability to challenge, interpret and translate them into competitive product solutions Accountable in defining and delivering programs and deliveries for the target Quality Management portfolio and Product Management Portfolio Act as a technology leader in the domain of Quality and Product Management Works in close collaboration with Service Performance Managers / Digital Operations teams securing appropriate SLAs for Quality Management solution are well stablish and respected Acts as extension of support them by providing L2 support on competitive advantage products Lead / Contribute on RFP / Partner selection process related to Quality Management project / product development and delivery. Works with Opella Global data organization to define and implement effective data governance (process / organization / tools) to support Opella transformation Instrumental on the short-, mid- and long-term sourcing of skills & talent definition for Opella and/or external parties. Ensures Product technology system meets all controls to address applicable quality, regulatory (Data Privacy, GxP, SOX, etc.) and cybersecurity requirements Education Bachelor’s Degree (B.A.) or equivalent in Information Technology / Manufacturing or Engineering Required Knowledge And/or Experience 10+ years of work experience, including 5+ years as a Quality Product Owner On Hands experience on Quality Management tools at site level On Hands experience in Data Management (product focus) tools Experience managing transversal teams Broad background in different sectors with a preference for previous FMCH experience Proven hands-on experience with modern technologies, development methods (Lean & Agile practices) and tools Proven experience from having led/steered programs in the Manufacturing / Quality Management domain Strong communication, negotiation, and interpersonal skills Demonstrated conflict resolution & problem-solving skills in a global environment Language Skills Fluent spoken and written English Required Leadership Competencies Strategic Thinking - ability to evaluate relevant areas of operation, formulate objectives and set priorities in a contextually relevant way, and develop plans consistent with long-term organizational interests. Judgement- The ability to draw logical conclusions based on acquired information and analytical rigor in problem-solving, the ability to make effective decisions even when information is ambiguous or incomplete. Team Leadership – Ability to build cohesive, high-performance teams that take accountability and achieve required results. Interpersonal relationships - treating others with courtesy, sensitivity, and respect. Change Leadership - The ability to demonstrate support and drive for innovation and organizational transformation. Personal Leadership - Personal leadership translates into courage, choice, and commitment through the pursuit of excellence, trust, and accountability. Ability to put patient, stakeholder, and organizational interests above personal interests. Drive -Takes the lead and initiates activities with a high degree of passion and commitment as well as the drive, desire and need to achieve challenging goals, to improve performance or to meet personal standards of excellence Why us? At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day. We Are Challengers. We Are Dedicated To Making Self-care As Simple As It Should Be. That Starts With Our Culture. We Are Challengers By Nature, And This Is How We Do Things All In Together: We keep each other honest and have each other's backs. Courageous: We break boundaries and take thoughtful risks with creativity. Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity. Radically Simple: We strive to make things simple for us and simple for consumers, as it should be. Join us on our mission. Health. In your hands. www.opella.com/en/careers Show more Show less

Job title: Expert, Master Data Quality & Performance Location: Hyderabad % Remote working and % of travel expected: 10% Job type: Permanent Job Purpose About the job Secure master data (MD) quality and availability at the Sanofi target Support master data quality improvement activities across all sites in the frame of M&S master data playbook Identify any master data quality and availability issues and propose solutions and remediation (continuous improvement spirit) Provide technical analysis on Masterdata and implementation of new scope Key Accountabilities MD operational responsibility Responsible the architecture and data modelling of the DataLab Bi-weekly update for enhancement, scope extension, and refresh of our Data product Monthly calculation of Masterdata KPIs. Publication, historization and failures for correctives actions Identification and sourcing of data (Snowflake). Close collaboration with Sanofi Data Foundation. Propose and design technical solution to topics relative to the DataLab, in collaboration with Sanofi Digital team Ensure the integrity of the tool and the correctness of the data sources Continuous improvement responsibility Driving continuous improvement for Master DataLab efficiency by identifying and raising initiatives to respective team lead Supporting Master DataLab evolutions, projects, and improvement initiatives by performing feasibility study and assessment Providing input for documentation, training materials, and knowledge management for the architecture, data modelling and technical part of the DataLab Master data user support and monitoring Supporting MD community on site level, for instance conduct impact analyses for upcoming site project Contributing to the education of the MD community About You Preferred skills/expertise/experience: Experience Minimum 3 years in Master Data Management with knowledge of pharma industry (e.g., GxP) Preferably, work experience / educational background in data analytics (covering supply chain mgmt. / logistics / pharma quality mgmt. / pharma manufacturing) Skills/expertise Strong understanding of Master Data Management, data governance frameworks local processes, and site systems Work experience with data analytics tools, data visualization (PowerBI and PowerApps), data sourcing (Snowflake, SP List, Power Automate), data processing (dbt) - Mandatory Work experience with SAP ERP (ECC 6.0, S/4H) / LIMS - Optional Mandatory English, preferably languages for key markets (French) Competency Requirements Being thorough and consistent Be a good communicator and team player to resolve ad-hoc issues Strong willingness to learn Sanofi values Stretch to go beyond the level we have operated at up until now Act in the interest of our patients and customers Take action instead of waiting to be told what to do Put the interests of the organization ahead of my own or those of our team Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! null Show more Show less

Position: Consultant – Pathology Location: Jaipur Employment Type: Full-time About Dr. B. Lal Clinical Laboratory Dr. B. Lal Clinical Laboratory Pvt. Ltd. is Rajasthan’s most trusted name in diagnostics, delivering precision, speed, and service to millions of lives. With NABL-accredited labs, cutting-edge technology, and a patient-first approach, we are redefining the future of quality diagnostics. Role Overview We are looking for an experienced and clinically driven Consultant Pathology to join our expert team. The role involves high-quality diagnostic reporting in Clinical Pathology, Hematology, and Biochemistry, along with active collaboration with clinicians to support patient-centric care and timely decision-making. Key Responsibilities Validate and authorize reports in clinical pathology, hematology, and biochemistry. Ensure compliance with NABL standards and internal quality protocols. Interpret complex findings and guide clinicians with medical insights. Proactively coordinate with referring clinicians for case discussions, clarifications, and result explanations. Participate in internal quality control (IQC), EQAS, and lab audits Mentor technical staff to ensure continuous skill development. Eligibility Criteria Education: MD/DNB in Pathology from a recognized institution Experience: 3–7 years in diagnostics (experience in NABL-accredited labs preferred) Deep understanding of hematology (e.g., peripheral smear), biochemistry, coagulation, and enzymology Proficient in LIMS, automated analyzers, and digital reporting systems Strong communication skills and a collaborative approach with clinicians Why Join Us? Opportunity to collaborate closely with clinicians and contribute to clinical outcomes Exposure to high-end diagnostic platforms and structured lab operations Clinically enriching environment with a focus on accuracy, compliance, and patient care Attractive compensation, learning opportunities, and a high-performance culture Be part of a trusted brand serving millions across Rajasthan and beyond Show more Show less

Lab Chemist Location: Kheda, Ahmedabad Experience Required: Minimum 2 Years Industry: Oil & Refinery Employment Type: Full-time Relocation: Accommodation Provided for Relocating Candidates Key Responsibilities: Conduct routine and non-routine laboratory tests on crude oil, intermediates, and finished products. Analyze samples using instruments such as GC, HPLC, AAS, FTIR, and other standard lab equipment. Ensure all testing is performed in accordance with established safety and quality standards (ASTM, BIS, ISO). Maintain accurate documentation of test results and prepare detailed reports for internal use. Support quality control and quality assurance processes to ensure compliance with regulatory requirements. Calibrate and maintain laboratory instruments and equipment on a regular basis. Collaborate with production and process teams to troubleshoot quality issues. Maintain a clean, safe, and organized laboratory environment. Required Qualifications & Skills: Bachelor’s or Master’s degree in Chemistry, Industrial Chemistry, or related field. Minimum 2 years of laboratory experience in the oil & refinery sector. Strong understanding of analytical techniques and lab safety protocols. Proficiency in using lab software and tools for data recording and reporting. Excellent attention to detail, organizational skills, and ability to work independently. Preferred Qualifications: Certification in Quality Assurance/Control or Lab Safety. Familiarity with LIMS (Laboratory Information Management Systems). Experience in ISO 17025 accredited labs is an added advantage. What We Offer: Competitive salary and benefits package. Company-provided accommodation for candidates relocating to Kheda. Opportunities for professional growth and technical training. A collaborative and safety-first work culture. Show more Show less