Posted:21 hours ago|
Platform:
Work from Office
Full Time
Deputy Manager - IPQA DS
Experience - 10-12yrs
1. Cell bank management
2. Issuance of line clearance
3. Upstream and Downstream batch record review
4. Routine IPQA activities
5. Hands on experience on digital systems such as Trackwise/ Veeva/ SAP/ LMS/ DMS/ E-Val etc.
6. Deviation, OOS, OOT investigation review and approval
7. Change control initiation, review, approval
8. CAPA initiation, review and effectiveness verification
9. Exposure to regulatory audits
10. Risk assessment review and approval
11. Process and cleaning validation
12. APQR preparation and review
13. Periodic Trending of QMS elements
14. Review and approval of environmental monitoring trends
15. Review and approval of study protocols, reports, qualifications etc
16. Monitoring of Dispatch activities.
17. Good documentation practices
18. Data integrity awareness
19. Batch release
20. Preparation and review of sampling plans
MSc Biotechnology, M. Tech Biotechnology or MSc in any other life sciences with IPQA experience in Biologics
Curateq Biologics
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