Quality Assurance Specialist

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
Job Description
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.
Strong 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:
shiti@talentleap.in

Work arrangement
No