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 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/work from Chandigarh office, as needed

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