Production Staff

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 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.