- Ensure compliance with GMP, GLP, GDP, and company SOPs.
- Prepare, review, issue, and control SOPs, BMRs, BPRs, specifications, and other quality documents.
- Review batch manufacturing records (BMR) and batch packing records (BPR) before batch release.
- Conduct line clearance before the start of manufacturing and packaging activities.
- Perform in-process quality checks during production and packing.
- Handle deviations, change controls, CAPA, OOS, OOT, and customer complaints.
- Review and approve analytical reports, certificates, and quality documentation.
- Conduct internal audits and support external regulatory audits.
- Monitor environmental conditions, housekeeping, and GMP compliance across production areas.
- Ensure calibration and validation activities are completed as per schedule.
- Coordinate with Production, QC, Warehouse, and Regulatory Affairs departments.
- Maintain document control and ensure proper record retention.
- Conduct GMP training for employees and maintain training records.
- Support product release activities and ensure compliance with regulatory requirements.
Required Skills
- Good knowledge of GMP, GLP, GDP, WHO-GMP, and regulatory guidelines.
- Understanding of pharmaceutical quality systems and documentation.
- Knowledge of CAPA, Change Control, Deviations, OOS, and OOT investigations.
- Strong documentation and analytical skills.
- Good communication and problem-solving abilities.
- Proficiency in MS Office and ERP systems is an added advantage.
Educational Qualification
- B.Pharm / M.Pharm
- M.Sc. (Chemistry, Microbiology, Biotechnology, or related discipline)
Experience
- 1–5 years of experience in Quality Assurance in a pharmaceutical manufacturing company.
Intersted Candidates Can share me your resume :- 90545 52040
Thanks & Regards
Anchal Chaube
Pay: ₹15,000.00 - ₹25,000.00 per month
Benefits:
- Cell phone reimbursement
- Food provided
- Provident Fund
Work Location: In person
