Pharmacovigilance (PV)/GCP QA Lead

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

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)

Job Description
- 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
- Strong written and verbal communication skills
- Detail oriented
- Passion for delivering high quality work
- Ability to manage multiple and wide-ranging tasks effectively
- High level of flexibility and ability to prioritize work
- Ability to perform under stringent timelines
- Ability to work independently or as a team member
- Excellent problem-sol

📌 PV Auditing (Chandigarh)
🏢 PERSOL
📍 Chandigarh