Position: Auditing & Quality Assurance Lead (PV)
Work mode: Hybrid
Experience: Minimum 10 years of relevant work experience in Quality Assurance Department for Pharmacovigilance
Location: Chandigarh

Performing QA activities (listed below) independently and/or in liaison with the Quality
Head:
• Handling client audits and regulatory inspections
• Management of quality issues/events/deviations and CAPAs
• Performing RCAs and/or providing guidance to the staff in performing RCAs
• Developing CAPA plans and/or providing guidance to the staff in developing and
implementing CAPAs
• Planning internal and vendor audits using a risk-based assessment and maintaining
the audit planner in accordance with applicable GVP and GCP requirements
• Preparing audit schedules and performing internal audits and audits of vendors
• Maintaining/managing controlled documents such as SOPs, templates etc.
• Liaising with Project Leads/Functional Heads for ensuring implementation of
applicable KPIs/metrics
• Reviewing the quality and compliance data of various projects; performing trend




analyses and interpretation of analyses
• Computer system validation activities
Note: This is only an indicative list, not an exhaustive list of responsibilities. Additional
activities may need to be performed.
Qualifications and skills:
• Degree in any of the Life Sciences disciplines (Pharmacy, Microbiology, Biochemistry,
Biotechnology etc.)
• Experience of ~10 years in PV and/or GCP and Quality Assurance
• High level of proficiency in English, particularly written English
• Auditing certification (e.g. ISO lead auditor/assessor certification)
• Auditing experience, specially planning for internal and vendor audits using
risk-based approach
• Experience in handling client/partner audits, and regulatory inspections
• Experience in performing RCAs and development of CAPAs
• Working knowledge of drug safety/GCP/regulatory requirements
• Robust written and verbal communication skills
• Detail oriented
• Passion

📌 Auditing & Quality Assurance Lead (Pharmacovigilance) (Chandigarh)
🏢 CONTINUUM India
📍 Chandigarh