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 57 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

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

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