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
Solid 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