Sr Manager

7 days ago


Hyderabad, India Curateq Biologics Full time

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:

  1. Mainly responsible to review of Harvest, Drug Substance and Drug Product analytical (Biosimilars) raw data and analytical trends
  2. Conduct Gemba walkthroughs in QC department and to ensure quality compliance.
  3. Involve in investigations (Deviations, OOS, OOT, Lab incidents) to ensure QMS compliance for QC sections
  4. Audit trails and conduct routine monitoring in QC to check effectiveness of the system implemented.
  5. Responsible for preparation and review of documents SOPs, Protocols, Reports, Trends, APQR, Annual trends etc
  6. Track Reference standards related studies and review of related documentation timely

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