Executive – Quality Assurance & Pharmacovigilance

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 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.

Skills & Competencies
• Knowledge of GMP, Schedule M, and Pharmacovigilance requirements.
• Good documentation, investigation, and analytical skills.
• Proficiency in MS Office applications.
• Strong communication and teamwork abilities.
• Attention to detail and compliance-oriented approach.