Role Overview
Sanofi is hiring a mid-level Quality Business Owner - PQR. This is a full-time role in IN. posted 2 days ago. Full responsibilities, required qualifications, and the apply link are listed in the description below.
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Job Description
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
Frequently Asked Questions
How do I apply for the Quality Business Owner - PQR position at Sanofi?
Use the Apply button above to submit your application directly to Sanofi. Most applications take less than 5 minutes if your resume and contact details are ready, and you'll be routed to the employer's official application system to finish.
Where is the Quality Business Owner - PQR position at Sanofi located?
This position is based in IN. Sanofi has not indicated remote or hybrid options for this role, so candidates should plan for on-site work.
What does a Quality Business Owner - PQR at Sanofi earn?
Sanofi has not disclosed a salary range in this posting. Many employers share specifics later in the interview process; you can also ask during a recruiter screen if compensation transparency is important to you.
When was the Quality Business Owner - PQR role at Sanofi posted?
This role was posted on June 17, 2026 (2 days ago). It's still listed as actively hiring; we re-confirm openings against the source system multiple times per day and remove closed roles.
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