PV Auditing & QMS Lead

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 varied 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-solving skills and decision-making skills
• Ability to understand, interpret, analyse and present data
• Computer proficiency: proficiency in the use of MS Office suite (Word/Excel/ Power

Point)

• Ability and willingness to travel, as needed