Posted:1 week ago|
Platform:
Work from Office
Full Time
1. Basic norms of cGMP are being followed.
2. To check conformance of activities with SOP.
3. Issuance and review of checklists/logbooks/formats to production/stores/engineering departments
4. Line clearance for the equipment/area.
5. To perform and monitoring of inprocess/process and cleaning validation sampling/unit operations as per approved procedures.
6. To ensure, labelling as per current procedures.
7. To verify compliance of audit observation on shop floor.
8. To ensure, online documentation and timely entries of all operations / activities.
9. Review of Audit trail and Electronic Data For computerized systems.
10. Review of Master Batch Manufacturing Record and related documents like cleaning SOP and Process flow chart.
11. Creation of SAP notification for Deviation.
12. Coordinating with investigation of Deviation/OOS/OOT as per approved procedures.
13. Responsible for approve/closure of Breakdown maintenance notification in SAP.
14. Handling and review of Risk Management by FMECA and Coordination for periodic FMECA for its completion.
15. Any other assignment allocated by Section head / Department Head
M.Sc Organic Chemistry with minimum 1 year experience in API QA Validation
Mohaneswara Reddy
https://www.linkedin.com/in/mohaneswarareddy
Cipla
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