- 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 the warehouse for product verification.
Pharmacovigilance
- Receive, review, and process Adverse Event (AE) / Adverse Drug Reaction (ADR) reports.
- Maintain pharmacovigilance records, databases, and trackers.
- Support case processing, follow-up activities, and regulatory reporting.
- Assist in preparation of PSURs, PSMF documentation, and PV compliance activities.
- Support pharmacovigilance audits and inspections.
Preferred candidate profile
- Knowledge of GMP, Schedule M, and Pharmacovigilance requirements.
- Good documentation, investigation, and analytical skills.
- Proficiency in MS Office applications.
- Solid communication and teamwork abilities.
- Attention to detail and compliance-oriented approach.