Posted:1 week ago|
Platform:
Work from Office
Full Time
-- Handle QMS activities: Change Controls, Deviations, CAPAs, and Event Investigations (TrackWise) ,
- Review and prepare GMP documents (SOPs, BMRs, BPRs).
-Conduct training programs on cGMP and SOPs as per TNI or schedule.
Troubleshoot production issues to prevent downtime.
-Ensure compliance with regulatory standards and internal SOPs.
- Maintain accurate documentation: batch records, equipment logs, quality reports.
Hands-on with equipment: autoclaves, DHS, PFS filling machines, mixing vessels, packing lines.
-Familiar with utilities: DG sets, HT Panels, Transformers.
- 8+years of experience in OSD/API manufacturing.
Desano
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