- Document Control & Management: Create, issue, review, update, and retrieve controlled documents such as Standard Operating Procedures (SOPs), batch records, and specifications.
- Batch Record Review: Inspect and verify Master Batch Manufacturing Records (MBMR) and Master Batch Packing Records (MBPR) for accuracy and compliance before product release.
- Audit & Inspection Readiness: Maintain secure archiving systems, manage document retention schedules, and provide historical records during internal or external regulatory audits.
- Quality Management Systems (QMS): Track and document quality events, including change controls, deviations, market complaints, and Corrective and Preventive Actions (CAPAs).
- Compliance Reporting: Prepare and compile Annual Product Quality Reviews (APQRs) and coordinate with production or regulatory teams for timely approvals.
- Training Coordination: Maintain training calendars, log employee completion records, and assess the effectiveness of quality and cGMP (Current Good Manufacturing Practice) training sessions.
Pay: ₹25,000.00 - ₹40,000.00 per month
Benefits:
- Flexible schedule
- Food provided
- Health insurance
- Internet reimbursement
- Leave encashment
- Life insurance
- Paid sick time
Education:
Experience:
- QA documantation: 3 years (Required)
Work Location: In person