Quality Assurance
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.
Positive documentation, investigation, and analytical skills.
Proficiency in MS Office applications.
Solid communication and teamwork abilities.
Attention to detail and compliance-oriented approach.