Posted:4 weeks ago|
Platform:
Work from Office
Full Time
Dear All,
1. Review of analytical raw data and reports pertaining to registration stability and compilation of stability data.
2. Review of analytical raw data for Raw materials, in process, finished product and pilot bio/exhibit batch.
3. Review of method transfer protocols, raw data, LNBs and reports.
4. Review of method verification & method equivalency, dissolution profiling protocols, raw data, LNBs and reports.
5. Qualification of spread sheets.
6. Review of Specifications, STPs and GTPs of raw material, packaging material, in-process and finished product (release & shelf life).
7. Review of Record of analysis for raw materials, packaging materials, in process and finished products.
8. Review of analytical method development, method validation and routine samples analysis raw data, LNBs and reports.
9. Review of Instrument/Equipment Calibration & Maintenance records.
10. Review of Instrument/Equipment qualification documents.
11. Preparation of Quality assurance SOPs and Guidelines.
12. Issue, control and archival of SOPs, guidelines, forms, logbooks, Laboratory Note Books and test methods.
13. Allotting the equipment/ instrument ID and scientist codes.
14. To assist during external audits by sponsors/clients/regulatory agencies.
15. Review of out of specification (OOS) and out of trend OOT reports
16. Incidents, Events & Change control management
17. Closing of Quality notifications.
Aizant
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