Job Description
We are seeking a Quality Assurance Officer specialized in injectables to join our team. The candidate will be responsible for various aspects of Quality Management Systems (QMS) and In-Process Quality Assurance (IPQA).
Role & Responsibilities for QMS – Injectables
- Document management
- Change control
- Handling of investigations (Deviation, CAPA, OOS, OOT, Market Complaint)
- Vendor qualification
- Equipment qualification and process validation
Role & Responsibilities for IPQA – Injectables
- Check documents like equipment log books, temperature, and humidity records
- Collect in-process and finished samples as per specifications and protocol
- Supervise RM/PM sampling and dispensing procedures
- Ensure machine line clearance of the production area
- Conduct area line clearance of the production area
- Check online tablet weight variation, hardness, friability, thickness, and disintegration time
- Verify granulation, compression, coating, and packing processes, and release the same
- Fill and check Batch Manufacturing Records (BMR)
- Work on Product Quality Review (PQR) and Initial Product Quality Review (IPQR)
- Approve batches and verify various documents
- Finalize the quality of finished goods
- Supervise sampling activity for in-process and finished samples for analysis
Requirements
- Required experience in injectables sterile formulation
- D.Pharm, B.Pharm, B.Sc., M.Sc., M.Pharm
- 3 to 8 years of relevant experience
Interested candidates can send their CV to: shivani.verma@ipca.com
