Job Title: Medical Quality Assurance (MQA)

? Location: Mumbai

? Experience: 2–5 Years

? Qualification: Master’s Degree or equivalent in Pharmacy, Science or a related field

? Industry: Pharmaceutical / CRO

We are hiring a Medical Quality Assurance (MQA) professional with experience in Pharmacovigilance (PV) and Clinical Trial (CT) auditing .

Key Responsibilities

- Ensure PV and Clinical Trial activities comply with internal procedures, regulatory requirements and industry standards.
- Develop and implement QA policies and SOPs for PV and CT activities.
- Plan and conduct risk-based audits.
- Conduct PV system audits , affiliate audits, licensing partner audits and service provider audits.
- Conduct audits of clinical research teams and investigator sites for Phase 3 & 4 clinical trials.
- Review audit responses, CAPA and effectiveness checks.




- Support global inspection preparation and inspection management.
- Support licensing partner audits, including audit responses and CAPA.
- Ensure audit reports and corrective/preventive actions are completed within defined timelines.

Required Skills & Experience
- 2–5 years of experience in a Pharmaceutical or CRO setting.
- Mandatory experience in GCP/PV auditing.
- Robust knowledge of ICH GCP, EU GVP and applicable regulatory requirements .
- Knowledge of clinical trial conduct.
- Ability to work independently and effectively in a multidisciplinary team.
- Willingness to travel domestically and internationally up to 30% .

? Interested candidates can share their CV at: [email protected]

📌 Quality Assurance Specialist (Mumbai)
🏢 Talent Leap Private
📍 Mumbai