Job Summary To support Quality Assurance and Pharmacovigilance activities by ensuring compliance with GMP requirements, quality systems, adverse event reporting, product complaint management, and applicable regulatory guidelines.
Key Responsibilities Quality Assurance (QA)
- Maintain and control SOPs, specifications, and quality records.
- Support deviation, change control, CAPA, OOS, and complaint investigations.
- Assist in internal audits, vendor qualification, and compliance monitoring.
- Review quality documentation and ensure timely closure of quality events.
- Support regulatory inspections and customer audits.
- Visit warehouses for product verification.
Pharmacovigilance (PV)
- Receive, review, and process Adverse Event (AE)
and Adverse Drug Reaction (ADR) reports.
- Maintain pharmacovigilance records, databases, and trackers.
- Support case processing, follow-up activities, and regulatory reporting.
- Assist in preparing PSURs, PSMF documentation, and PV compliance records.
- Support pharmacovigilance audits and inspections.
Skills & Competencies
- Knowledge of GMP, Schedule M, and Pharmacovigilance requirements.
- Positive documentation, investigation, and analytical skills.
- Proficiency in MS Office applications.
- Strong communication and teamwork abilities.
- High attention to detail and a compliance-oriented approach.
QUALIFICATION B.Pharm / M.Pharm / Pharm.D / Life Sciences
📌 Executive – Quality Assurance & Pharmacovigilance (Mumbai)
🏢 YO IT CONSULTING
📍 Mumbai
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