Role & responsibilities for QMS- Injectable’s.
1) Document management.
2) Change Control.
3) Handling of investigations ( Deviation, CAPA, OOS, OOT, Market Complaint)
4) Handling of vendor qualification.
5) Handling of Equipment qualification and Process Validation.
Role & responsibilities for IPQA-Injectable’s.
- To check documents like equipment log books, temperature & humidity records,
- Collect in-process and Finished sample as per Specifications and Protocol.
- Supervision of RM/PM Sampling and dispensing procedure.
- Machine Line clearance of Production Area .
- Area Line Clearance of Production area
- Checking online tablet weight variation, hardness, friability, thickness & DT Time & check informality of weight.
- Verification of granulation, Compression, Coating, & Packing process & also release for same.
- Able to fill And Check BMR, Able to Work At PQR, IPQR.
- Able to Give Batch Approval, verify various Documents.
- Able to finalize Quality of Finished goods.
- Supervision of sampling activity for in process and finished samples for analysis
Qualification : D.Pharm, B.Pharma, B.Sc., M.Sc., M.Pharma
Experience : 3 to 8 years, Required experience of injectable’s sterile formulation only.
Mail your CV at: [email protected]
