Production /QMS Staff

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.