Department - Production QMS (Parenteral Operations)
Location - Zydus Biotech Park (Unit 9 Fill & Finish)
Position: Executive / Sr. Executive / Assistant Manager
Experience: 4–8 years
Qualification: B.Pharm / M.Pharm / M.Sc / B.SC
Industry: Sterile/Parenteral/Injectable Manufacturing
Key Responsibilities for Production QMS
- To review documents prepared by other colleagues.
- To maintain cGMP regulations in the area.
- To prepare and review of the SOPs, MFR, MPR, BPR, BMR.
- To prepare risk assessment for facility / equipment / process modification and introduction of new products.
- Responsible to handle introduction of new products.
- Responsible for preparation of process validation and report.
- To initiate change controls for manufacturing and packing operations / documents.
- To implement corrective actions related to gaps identified in the manufacturing and packing operation.
- To prepare alarm trend reports.
- To response observations related to internal audit and regulatory audits such as US FDA.
- To prepare study protocols as per requirements.
