Department - Production QMS

Designation - Sr Executive/ Asst Manager

Job Role & Responsibility

- Person should have experience and understanding of sterile drug product manufacturing and packing operation..
- 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 current 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.

📌 Production Staff (Ahmedabad)
🏢 Zydus Lifesciences
📍 Ahmedabad