 
						Sr Manager
13 hours ago
Role & responsibilities
Suggested position: Sr Manager / Manager
Education: Post Graduation (Life sciences preferred)
Total Exp: 15-17 Years (Biopharma is preferred)
Others: Ready to support in different shifts
Responsibilities:
- Mainly responsible to review of Harvest, Drug Substance and Drug Product analytical (Biosimilars) raw data and analytical trends
- Conduct Gemba walkthroughs in QC department and to ensure quality compliance.
- Involve in investigations (Deviations, OOS, OOT, Lab incidents) to ensure QMS compliance for QC sections
- Audit trails and conduct routine monitoring in QC to check effectiveness of the system implemented.
- Responsible for preparation and review of documents SOPs, Protocols, Reports, Trends, APQR, Annual trends etc
- Track Reference standards related studies and review of related documentation timely
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