Manufacturing and Supply
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miracles of
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Job Title- Quality Business Owner - PQR

Location- Goa

About the Role

Implement Quality management systems & Compliance at the Goa Pharma site, adhering to global quality documents and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet customers' requirements, living the Group's Values and Code of Ethics.

As the Quality Business Owner for Product Quality Review (PQR), you will serve as the site's primary owner of the PQR process, system, and data — driving quality excellence, regulatory compliance, and continuous improvement across operations.

Key Responsibilities

Primary Accountabilities

• Serve as Business Owner of Product Quality Review (PQR) for the site, owning the process, system, and data end-to-end
• Conduct regular routine data quality checks and validations to identify and address any process, system, or data issues
• Develop and deliver training programs on quality principles and practices
• Identify and assess risks related to processes in scope and implement mitigation strategies
• Support continuous improvement initiatives on site, aligned with global processes and practices
• Oversee computerized systems associated with the process to ensure they meet all requirements
• Establish and monitor key performance indicators (KPIs) in line with global guidance
• Represent the site in the Community of Practice (CoP) led by global teams; participate in CoE as requested and ensure local communication

Decision-Making & Leadership

• Establish and prioritize process evolutions for the site
• Support audits and inspections; present processes to auditors and inspectors
• Proactively identify remediation actions from findings from internal and external audits, under control of the global process owner
• Stay informed of inspections and audits outcomes

Site-Specific Responsibilities

Change & Deviation Management:

• Initiate, implement, and close change controls
• Initiate deviations and support deviation investigations
• Implement assigned CAPAs (Corrective and Preventive Actions) and support closure
• Implement assigned Efficiency Reviews (ERs)

Batch & Product Quality:

• Perform batch release activities and respond to queries from the Qualified Person (QP)
• Support Market Complaint investigations
• Support OOS/OOT (Out of Specification / Out of Trend) reviews
• Compile Product Quality Reviews

Operations & Compliance:

• Provide quality oversight on shopfloor operations
• Conduct line clearance in Production areas
• Manage Data Integrity aspects across operations
• Participate in and support Opex initiatives
• Ensure adherence to Indian local regulations for batch release activities

Documentation & Systems:

• Review and approve GxP documents
• Review Quality Control documents, calibration documents, and logbooks
• Review Master Batch Records and executed Batch Records
• Manage user access and conduct periodic reviews
• Perform audit trail reviews
• Manage computerized systems associated with the process

Training & HSE:

• Coordinate cGMP training activities, including personnel training and review of training modules
• Ensure adherence to all Health, Safety & Environmental (HSE) aspects as required by company policies and procedures
• Implement HSE systems, maintain safe working conditions, and foster a culture of continuous improvement
• Support qualification activities

🎓 Required Qualifications

Education

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field

Experience

• Minimum 5–7 years of experience in pharmaceutical quality assurance
• Proven experience in Product Quality Review (PQR) processes
• Experience with regulatory inspections and audits (FDA,local health authorities)
• Strong background in cGMP compliance and quality systems

Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

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Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com