Executive – Quality Assurance & Pharmacovigilance

Department: Quality Assurance & Pharmacovigilance

Location: BKC, Mumbai

Experience: 1–2 Years

Qualification: B.Pharm / M.Pharm / Pharm.D / Life Sciences

Salary: Up to ₹3–3.5 LPA

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

- 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.
- Solid communication and teamwork abilities.
- Attention to detail and compliance-oriented approach.

Pay: ₹25,000.00 - ₹30,000.00 per month

Application Question(s)

- Qualification: B.Pharm / M.Pharm / Pharm.D / Life Sciences
- Support Quality Assurance activities including SOPs, quality records, deviations, CAPA, OOS, change controls, complaints, audits, and compliance monitoring.

Education:
- Bachelor's (Required)

Location:
- Mumbai, Maharashtra 400051 (Required)

Work Location: In person

📌 Quality Assurance & Pharmacovigilance (Mumbai)
🏢 Flysoft
📍 Mumbai