.1 Documentation - Should know about activity in brief
- BMR preparation as per liquid injection processes PFS and Vial.
- BMR preparation as per dry power injection process.
- BMR preparation as per FFS Process
- Manufacturing and filling process of injection
- Media fill operation and documentation.
- Preparation of BMR with respect to media fill activity
- Compilation of data and reports
- Should know about Process and TS validation
- Should handle the USFDA and regulatory audits
1.2 Process Validation and Compilation
- Should able to know about the Injection process validation
- Should work on PASX before is more preferable
- Should capable to handle all the trouble shooting during the process validation
- Should part of process improvement and optimization before this
- Should know about the regulatory requirement
1.3 Preparations of operational and process SOP.
1.4 Co-ordination with CFTs (i.e. Production, QA, QC) for exhibit exhibition, process validation, BMR activity and various documentation
1.5 Should independent handling of process validation of Injection.
1.6 Should know about the Product transfer activity from site to site.
Should know about the Packaging activity is more preferable