Website Zydus group ltd
Post Name: Production /QMS Staff
Job Description:
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.
