Pharmacovigilance QA Auditor role at Sun Pharma in Gurugram – BDS Candidates Apply Now
Looking to advance your career in pharmacovigilance? Sun Pharmaceutical Industries Ltd is hiring a Pharmacovigilance QA Auditor in Gurugram. This Pharmacovigilance QA Auditor role offers a unique opportunity to develop global auditing programs, manage quality assurance processes, and collaborate with cross-functional teams to ensure compliance with international pharmacovigilance standards. Join a company that values growth, collaboration, and continuous learning.
About the Company
Sun Pharmaceutical Industries Ltd is a leading global pharmaceutical company dedicated to providing high-quality, affordable medicines. With a strong focus on research and development, Sun Pharma strives to improve patient outcomes through innovation, compliance, and excellence in quality assurance. The company fosters a culture of growth, collaboration, and continuous learning, making it an ideal workplace for professionals seeking to advance their careers in pharmaceuticals.
Job Details:
- Job Title: Pharmacovigilance QA Auditor
- Location: Gurgaon – Office
- Business Unit: R&D Quality
- Job Grade: Executive / G12A
- Location: Gurugram, H.R.
Key Responsibilities:
- Assist in developing a global Pharmacovigilance system auditing program and responsible for conducting and reporting audits as a lead auditor/co-auditor for outsourced parties (CROs, Service Providers, Vendors), Affiliates & Partners, etc., associated with Sun Pharma Pharmacovigilance operations.
- Assist in conducting and reporting audits for Sun Pharma sites associated with Pharmacovigilance activities/ operations to assure adequacy & adherence with established Quality Systems.
- Management of Internal Audit Observation Database (IAOD) with the perspective of sharing audit reports, CAPA reports, and observation of global impact with all internal regional PV sites across the globe and Global Pharmacovigilance.
- To ensure that the CAPAs are adequately addressed and closed.
- To review and close deviations raised at global and regional levels in order to ensure adequacy of associated CAPA.
- Responsible for review of Pharmacovigilance SOPs for completeness, clarity, and compliance to global/regional policies, and applicable regulatory regulations & guidelines.
- To prepare and review departmental SOPs
- To assist in monthly report preparation
- Management training and records of GPvP-QA team through LMS
- Support operations team during corporate audit/ external audits
- Collaborate with cross-functional teams to ensure quality standards are met across all pharmacovigilance activities.
- Lead the assessment, tracking of global actions and monitoring of identified actions as part of various corporate initiatives.
- To perform any other responsibilities assigned with regards to the R&D Quality system.
- Maintain documentation and records in accordance with quality and regulatory standards
Education and Experience:
- BDS
- Around 2 years of experience in Pharmacovigilance Quality Assurance OR 2 years’ experience in PSUR/Signal management
Technical Competencies:
- Auditing skills
- Attention to detail
Behavioural Competencies / Soft Skills:
- Good spoken and written English
- Liaising with different teams
