Meglus pharmacutical PVT LTD

Role & responsibilities Job Title: Quality Assurance (QA) Officer Department: Quality Assurance Location: Piplaj , Ahmedabad Job Responsibilities: 1. Quality Compliance & Documentation: Ensure compliance with cGMP, GLP, and company SOPs across all departments. Review and control of Batch Manufacturing Records (BMRs) and Batch Packing Records (BPRs) . Ensure proper documentation and archival of all QA records as per GDP (Good Documentation Practices) . Review and preparation of Annual Product Quality Reports (APQRs) . Review and maintain calibration and validation documentation for all instruments and equipment. Review and maintain records for documentation issuance, retrieval, and control. 2. Process Monitoring & Audits: Conduct in-process checks and line clearances during manufacturing and packaging. Participate in internal audits and assist during regulatory inspections (WHO, GMP, etc.). Perform internal audits and submit reports to facility management. Assist in audit preparation (regulatory, third-party, and customer audits). Monitor deviations, change controls, CAPA, and OOS/OOT investigations. 3. Validation & Qualification: Review, preparation, and participation in qualification and validation activities . Verify temperature mapping activities for equipment, instruments, and areas. Monitor and compile data related to equipment/instrument qualification and validation . 4. SOP & Training Management: Assist in the preparation, review, and revision of SOPs, specifications,and validation protocols. Prepare and review all SOPs for the facility as per regulatory requirements. Maintain and update training records for all employees. Support and conduct training programs related to GMP compliance and quality systems . 5. Coordination & Vendor Management: Coordinate with Production, QC, and Warehouse teams to ensure consistent product quality. Participate in vendor qualification activities as per company SOPs. Support management in continuous improvement initiatives and compliance projects. Required Qualifications: Education: B.pharm ,B.Sc. / M.Sc. Experience: 1 to 2 years in a Quality Assurance role Skill Set: Strong knowledge of cGMP, GLP, and GDP practices. Excellent documentation and analytical skills. Good coordination and communication abilities. Strong attention to detail and compliance mindset. Work Hours: 9:30 AM to 6:00 PM Monday to Saturday Company Details: Meglus Pharmaceutical Pvt. Ltd. Piplaj, Ahmedabad, Gujarat