Title: Sr. Manager – R&D Quality (PV-QA)
Date Posted: April 25, 2025
Location: Gurgaon – Office
Company: Sun Pharmaceutical Industries Ltd
Job Overview:
Sun Pharma is seeking a Senior Manager in R&D Quality (GPvP QA) for its Pharmacovigilance Quality Assurance team based in Gurgaon. This strategic leadership role focuses on ensuring the implementation of global QA programs, regulatory compliance, auditing, and quality system governance within pharmacovigilance operations and computerized systems.
Department: R&D Quality (GPvP QA)
Designation: Senior Manager
Location: Gurgaon
Key Responsibilities:
Implement and maintain a documented QA program compliant with global and regional pharmacovigilance regulations.
Lead and conduct audits (Sun Pharma sites, CROs, vendors, affiliates, and partners) to ensure PV quality compliance.
Manage the Internal Audit Observation Database (IAOD) and CAPA lifecycle.
Harmonize and implement quality systems and SOPs across PV functions.
Conduct Quality Review Board (QRB) meetings for PV.
Prepare monthly QA performance reports for submission to the R&D Quality Head.
Ensure regulatory inspection readiness across all Sun Pharma PV sites and drive CAPA implementation post-inspections.
Conduct PV procedural and induction trainings for QA and operations personnel.
Oversee and ensure compliance of GxP Computerized Systems at the R&D Gurgaon site.
Serve as Process Quality Lead (PQL) for validation of computerized systems.
Review and manage system documentation: CSVMPs, system inventory, deviation logs, change controls, and periodic quality activities.
Support corporate audits and participate in remediation tracking and risk management for computerized systems.
Perform additional responsibilities as assigned by R&D Quality leadership.
Education and Experience:
Postgraduate in Pharmacy (M. Pharm) or Pharmacology
Approximately 15 years of relevant experience in Pharmacovigilance QA and R&D Quality functions
Technical & Behavioral Competencies:
Strong auditing and documentation skills
Effective verbal and written communication in English
Leadership and people management capabilities
Strong cross-functional collaboration and stakeholder liaison skills
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