Lupin Limited
Designation : Senior Executive
Function : Manufacturing
Functional Area : Technology Transfer
Job Role Summary : Preparation of Tech Transfer documents, Monitor manufacturing processes, Technology transfer, Suport regulatory dossier preparations
Job Profile :
- 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.Â
Job Requirements :
- Experience in Pharma R&D, Technology Transfer, Scale up, exhibit batches.
- Expertise in GMP and regulatory requirements
Work / Job Experience : 10-15 Years
Type of Experience : Pharma Formulation R&D, Technology transfer, manufacturing
Academic Qualifications :
Masters
Post Graduation in Biotechnology or Biochemistry
