Senior Executive
Apply now »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
Work Experience
10 – 15 years