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