Posted:5 hours ago|
Platform:
Work from Office
Full Time
1. Review of Analytical Method Validations/ Verifications protocol/ reports
2. Review of Analytical Method Transfer protocol/ reports
3. Review & release of Reference standard characterization data
4. Review of R&D data and Lab note book for regulatory submission
5. Review of Instrument/Equipment Qualification & Calibration reports
6. Review of CSV (Software Qualification) documents (Protocol &Reports)
7. Review of DS & DP STPs (Reference standard, Raw Material, Intermediate, In process, Semi finished & Finished product).
8. Preparation, Review & training of CQA SOP (Related to R&D Labs)
9. Review of SOPs for R & D function (Analytical Research Laboratory, DDRL (Pilot Laboratory), Engineering Department.
10. Investigation & Review of QMS events & related CAPA
11. Review of Change controls
12. Conduct Internal audits & Walkthrough rounds of R&D Labs
13. Review of Pilot BE/ Assessment Batches manufacturing documents (BMR/BPR)
14. Review of Equipment performance qualification
15. Review of AHU qualification
16. Issuance, archival & retrieval of SOP related formats, registers and logbooks and documents (Protocol/ reports etc.)
17. Should have knowledge of handling electronic platform (TWD, S4 HANA, LIMS, DMS etc)
18. Should have well aware about regulatory Guidelines and 21 CFR part 11 requirements
19. Assist to continuous review and updating of existing procedures and systems to comply with current regulatory guidance’s, CGMP and USV company policies.
20. Assist to implement current Pharmacopoeial updates and Regulatory guidance requirements.
21. To co-ordinate with different functions at sites, R&D Labs and other corporate functions for smooth functioning of operational activities.
USV
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