About the role
1. Preparation and review of the manufacturing and packaging Technical Direction.
2. Preparation of SOPs pertaining to In-Process QA.
3. Line Clearance during all critical process during Dispensing, Manufacturing, Filling & Stoppering and Packing operation.
4. Verify the dispensing of RAW Material and Packing Material.
5. In Process checking during dispensing , manufacturing, filling lyophillization, sealing, optical inspection, labeling and packing operation.
6. Sampling of process Validation Batches.
7. Sampling of In - Process and finished products and validation activities.
8. Collection of swab and rinse sampling after cleaning of equipment's and area.
9. Collection, Storage, Handling, Inspection and destruction of reserve samples.
10. Review Executed Exhibit and commercial Batch Manufacturing Records and packaging Record for release of finished Product.
11. To Monitor and verify any qualification of the process, equipment and system.
12. To Perform role of QA oversight and observe the compliance to SOP and aseptic behavior and indentify the deficiencies, if found any.
13. To Excute the Aseptic Core Monitoring during batch processing activity.
14. To participate in Media fill activities and ensure the review and compliance of the activity as per the Batch Records and protocols.
15. Preparation of PQR data for the product manufactured in year on rolling basis.
16. Collection and evaluation of Batch process parameters(CPP), Quality attributes from batch record and analytical record.
17. To review the Non Viable trends of Production Area.
18. To Perform any other works as and when assigned by HOD.