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
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, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
Skills Required
- Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or related field
- Minimum 5-7 years 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
- Experience managing computerized GxP systems, user access, and audit trail reviews
- Experience implementing and closing change controls, deviations, CAPAs, and ERs
- Experience in batch release activities, OOS/OOT investigations, and complaint support
- Ability to develop and deliver quality and cGMP training programs
Sanofi Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Sanofi and has not been reviewed or approved by Sanofi.
-
Retirement Support — Retirement support stands out through a notably strong 401K matching structure (e.g., 150% match up to a 6% contribution), which materially boosts total rewards for long-tenured employees.
-
Parental & Family Support — Parental and family support is positioned as unusually robust, including a global gender-neutral paid parental leave standard (14 weeks) and added supports such as childcare assistance and adoption/surrogacy/infertility help.
-
Equity Value & Accessibility — Equity participation is made more accessible via an Employee Stock Purchase Plan that includes a meaningful purchase discount and matching/free-share mechanics, increasing perceived total compensation beyond base pay.
Sanofi Insights
What We Do
We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Interactions with this account must comply with the Terms: https://bit.ly/sanofi-terms
