Title:  Manager - Engineering (OSD)

Role : Manager Engineering & Projects (OSD)

Location : Poanta 

Exp - 14 to 15 Yrs

1. Ensure compliance to cGMP and safety regulations.
2. Ensure compliance to maintenance of process equipment as per SOP.
3. Review and approval of all SOP’s related to process equipment’s.
4.  Approval and review of QMS (Deviation, CCR, CAPA) periodically.
5. Create purchase requisition of the critical spare procurement and its inventory.
6. Audit compliance of engineering documents and compliance of points observed from any regulatory as well as internal audit.
7. Support to validation team for periodic validation of process equipment
8. Initiation of deviation, change control, investigation and CAPA in Trackwise.
9. Monthly review of KPI with respect to maintenance of process equipment and appropriate corrective and preventive action.
10. Follow up for AMC services.
11. Compliance and response to records of process equipment’s.
12. Review of all cGMP records of Pharma maintenance.
13. Ensure timely training completion of sub-ordinates.
14. In-house projects, vendor coordination.