Senior Executive

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Date: Mar 5, 2025

Location: Pune Biotech, MH, IN

Company: Lupin

Long Description

  • Monitor the manufacturing process (Drug Product) and batch trend analysis.
  • Data acquisition, trending and analysis.
  • Preparation / review of documents pertaining to tech transfer like Development report, Tech transfer report, MFR, BMR and BPR w.r.t. drug product.
  • Review aseptic product filling operations such as formulation, filtration, filling, visual inspection and secondary packing operations on shop floor as and when required.
  • Technology transfer of new / existing products from sending unit (R&D) to receiving unit (Manufacturing) or from site-to-site transfer.
  • Responsible for preparation of Process Validation protocols / reports, QRMs, supporting PV on shop floor as and when required.
  • Responsible for writing technical documents such as scientific justification and evaluation.
  • Troubleshooting the problems and investigations using investigation tools for root cause analysis in a holistic manner as and when required.
  • Supporting regulatory for Dossier filing and giving technical inputs in respective sections.
  •  Review of process related change controls, co-ordinate the approval process and follow up to close out. 

Competencies

Education

Masters
Post Graduation in Biotechnology or Biochemistry

Work Experience

10 – 15 years

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