Senior Executive

Job Description

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