Job Summary

The role involves supporting Quality Assurance and Pharmacovigilance activities, maintaining quality documentation, assisting with adverse event reporting, and supporting compliance with applicable pharmaceutical quality and drug safety guidelines.

Key Responsibilities

Quality Assurance

• Maintain SOPs, specifications, and quality records.
  

• Assist in deviation management, CAPA, OOS, change control, and product complaint investigations.
  

• Support internal audits, vendor qualification, and quality compliance activities.
  

• Review quality documents and track closure of quality-related issues.
  

• Assist during regulatory inspections and customer audits.
  

• Conduct warehouse visits for product verification.
  

Pharmacovigilance

• Receive, review, and process Adverse Event (AE) and Adverse Drug Reaction (ADR) reports.
  

• Maintain pharmacovigilance records, databases, and trackers.
  

• Assist with case processing, follow-ups, and regulatory reporting.
  

• Support PSUR preparation and PSMF documentation.
  

• Assist with pharmacovigilance compliance activities, audits, and inspections.
  

Required Skills

• Knowledge of Quality Assurance and Pharmacovigilance.
  

• Understanding of GMP and Schedule M requirements.
  

• SOP management and quality documentation.
  

• Knowledge of CAPA, deviations, OOS, and change control.
  

• Internal audit and product verification.
  

• AE/ADR case processing and reporting.
  

• Understanding of PSUR and PSMF documentation.
  

• Working knowledge of MS Office.
  

Candidate Profile

Candidates with 1–3 years of relevant experience in pharmaceutical Quality Assurance or Pharmacovigilance and a degree in B.Pharm, M.Pharm, Pharm.D, or Life Sciences may apply.

Employment Details

• Job Location: Mumbai
  

• Work Arrangement: Work from Office
  

• Working Days: 6 days per week
  

• Annual CTC: ₹3–4 LPA