1. Core QMS Element Management & Documentation
- Deviation Management: Coordinate and review tablet/capsule manufacturing and packaging line deviations, ensuring rigorous root-cause analysis (e.g., Fishbone, 5-Why).
- CAPA (Corrective and Preventive Actions): Log, track, and verify the implementation and effectiveness of CAPAs to prevent issues like tablet capping, weight variation, or capsule splitting from recurring.
- Change Control: Author and process change controls regarding manufacturing equipment (e.g., compression machines, encapsulation lines, blister packers) or batch size scale-ups.
- Investigation Handling: Execute detailed quality investigations for Market Complaints, OOS (Out of Specification), and OOT (Out of Trend) laboratory results.
2. Batch Record & Technical Review (Tablets/Capsules)
- BMR & BPR Review: Thoroughly review executed Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) for completeness, yield reconciliations, and compliance with data integrity principles (ALCOA+) before releasing product batches.
- Master Documentation Support: Help in drafting, updating, and issuing master production formulas, Standard Operating Procedures (SOPs), and logbooks.
- APQR (Annual Product Quality Review): Compile and analyze trending data for tablet and capsule parameters (such as dissolution curves, hardness, friability, and assay values) to prepare annual reports.
3. Validation, Calibration, & Lifecycle Tracking
- Validation Protocols: Review and archive protocols and execution data for Process Validation, Cleaning Validation (ensuring no cross-contamination between different drug molecules), and Equipment Qualifications (IQ/OQ/PQ).
- Calibration Schedules: Track and maintain records for the calibration and preventive maintenance of tablet/capsule equipment and QC laboratory testing instruments. [1, 2]
- Technology Transfer Documents: Review technical transfer and validation packages coming from formulation research & development (FR&D).
Pay: ₹30,000.00 - ₹40,000.00 per month
Benefits:
- Flexible schedule
- Food provided
- Health insurance
- Internet reimbursement
- Leave encashment
- Life insurance
- Paid sick time
- Provident Fund
Education:
Experience:
- QMS Documantation: 5 years (Required)
Work Location: In person
