Are you an experienced professional in Pharmacovigilance Quality Assurance (PV-QA) looking for an exciting career opportunity? Sun Pharmaceutical Industries Ltd, a leading global pharmaceutical company, is hiring for the position of Executive – R&D Quality, GPvP-QA (Pharmacovigilance Auditor) at its Gurgaon office. This is your chance to contribute to a robust global pharmacovigilance system while working with a renowned organization.
Job Overview: Executive – Pharmacovigilance QA Auditor
- Position: Executive – R&D Quality, GPvP-QA (Pharmacovigilance QA Auditor)
- Grade: G12A
- Number of Positions: 2
- Job Location: Gurgaon, Haryana
- Department: Pharmacovigilance Quality Assurance (PV-QA)
Sun Pharma is seeking two dedicated professionals to join its Pharmacovigilance Quality Assurance team. This role involves auditing pharmacovigilance operations, ensuring compliance with global standards, and maintaining high-quality systems across outsourced partners, affiliates, and internal sites.
Key Responsibilities of the Pharmacovigilance QA Executive
As a PV-QA Auditor, you will play a critical role in upholding Sun Pharma’s pharmacovigilance standards. Your responsibilities will include:
- Audit Program Development & Execution:
- Assist in designing and implementing a global Pharmacovigilance auditing program.
- Conduct audits as a lead auditor or co-auditor for outsourced parties (CROs, vendors, service providers), affiliates, and partners linked to Sun Pharma’s pharmacovigilance operations.
- Perform audits of internal Sun Pharma sites to ensure adherence to established Quality Systems.
- CAPA Management:
- Prepare and maintain a CAPA tracker, ensuring corrective and preventive actions (CAPAs) are addressed and closed effectively.
- Review and close deviations at global and regional levels to ensure robust CAPA implementation.
- SOP & PSMF Oversight:
- Review Pharmacovigilance SOPs for completeness, clarity, and compliance with global and regional regulations (e.g., GVP modules).
- Evaluate Pharmacovigilance System Master Files (PSMFs) for assigned countries.
- Vendor & Risk Management:
- Support risk assessments of business partners.
- Participate in the qualification of vendors providing pharmacovigilance support.
- Database & Schedule Management:
- Manage the Internal Audit Observation Database (IAOD) to share audit reports, CAPAs, and observations globally.
- Update the audit master schedule for GPvP-QA audits.
- Additional Duties:
- Perform tasks assigned by the Head of GPvP-QA as needed.
Desired Candidate Profile
Sun Pharma is looking for candidates who meet the following criteria:
- Educational Qualification: M. Pharm (Master of Pharmacy)
- Experience: 2-3 years in Pharmacovigilance Quality Assurance (PV-QA) or pharmacovigilance operations
- Preferred Knowledge: Familiarity with Good Pharmacovigilance Practices (GVP) modules
- Skills:
- Strong oral and written communication skills
- Analytical mindset with attention to detail
If you’re passionate about R&D Quality, auditing, and ensuring compliance in pharmacovigilance, this role is perfect for you!
