Job Title:
Senior Manager – R&D Quality (PV-QA)
Company:
Sun Pharmaceutical Industries Ltd
Location:
Gurgaon, India
Job ID / Posting Date:
Posted on April 25, 2025
Department:
R&D Quality (Global Pharmacovigilance Quality Assurance - GPvP QA)
Employment Type:
Full-time
Role Summary:
The Senior Manager – R&D Quality (PV-QA) is responsible for developing and implementing robust Pharmacovigilance Quality Assurance programs to meet global and regional regulatory compliance standards. The role includes leading audits, ensuring inspection readiness, overseeing CAPA management, and supervising validation of GxP computerized systems at the Gurugram R&D site.
Key Responsibilities:
Implement and maintain a well-defined QA program aligned with global PV regulations and internal SOPs.
Lead/co-lead audits of Sun Pharma sites and outsourced vendors involved in PV activities.
Maintain the Internal Audit Observation Database (IAOD) and audit master schedules.
Monitor and ensure timely CAPA closure from audits and deviations.
Conduct Quality Review Board (QRB) meetings for the PV function.
Review and develop SOPs and provide induction and procedural training to QA personnel.
Oversee regulatory inspection readiness at global PV sites.
Supervise computerized systems validation (CSV) and ensure compliance across their lifecycle.
Act as Process Quality Lead (PQL) for validation of computerized systems at the Gurugram PVG site.
Approve and maintain documentation such as CSV Master Plans, system inventories, and QMS records (Deviations, CAPA, Change Control).
Lead remediation efforts for audit findings and corporate initiatives.
Education & Experience:
Education: Postgraduate in Pharmacy (M.Pharm) / Pharmacology
Experience: Around 15 years in Pharmacovigilance QA or related roles
Technical Competencies:
Strong auditing and compliance knowledge in GxP and Pharmacovigilance
Familiarity with computerized systems validation (CSV)
Documentation and risk management expertise
Behavioral Competencies / Soft Skills:
Excellent written and verbal communication in English
Strong people management and cross-functional collaboration
Effective liaison with internal and external stakeholders
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