Experience Range : 5 – 15 Years
Qualification : Bachelor of Pharmacy (B.Pharma), Master of Pharmacy (M.Pharma)
1. Monitoring of manufacturing activities by in process checks, sampling and ensure Online Documentation.
2. Ensuring and providing Line-clearance for all the activities at each process (manufacturing, filling, sealing, inspection and packing) stage.
3. Monitoring of Entry, Exit and Gowning Procedure for the compliance.
4. Monitoring and Ensuring Personnel Hygiene and Environmental monitoring in Production.
5. Monitoring of GMP records.
6. Coordination for collection of samples for Validation, Stability, QC and other (if any).
7. Timely reporting of incidents, deviations, change control with respect to shop floor activities.
8. To update his knowledge with respect to new procedure, guidelines or any regulatory requirements.
9. Microbiological Monitoring of manufacturing area (Environmental & personnel) in grade A, B and grade C area.
10. Responsible for preparation of Batch Processing Record (BPRR) and Batch Packing Record (BPAR)
11. Verifying BPRR and BPAR after execution to ensure the process compliance in all aspects and release the product.
12. Stage wise process verification of BPRR and BPAR for compliance
13. To perform air flow visualization study (smoke study) as per approved protocol/sop.
14.Any other job assigned by Reporting Head.