Engineering - Head Pharmaceutical background only

Role & responsibilities

1. Overall responsibility for sterile and non-sterile area.

2. Overall responsibility to maintain the record for the sterile and non-sterile area machineries.

3. Overall responsibility for maintaining all history card of for sterile and non-sterile area.

4. Overall responsibility for all types of breakdown for various machineries in for sterile and non-

sterile area.

5. Overall responsibility for all new machine installation & its engineering services.

6. Overall responsibility for all audit related compliance of for sterile and non-sterile area.

7. Overall responsibility for putting the requirement of required spares and rectification of breakdown machineries in for sterile and non-sterile area.

8. Overall responsibility for factory premises maintenance planning and execution.

9. Overall responsibility to ensure compline of engineering SOPs and other SOP as per quality system.

10. Overall responsibility for QMS documents related to engineering.

11. Overall responsibility to maintain documents as per cGMP & GDP.

12. Responsible for continuous upgradation of facilities, equipment and system for production of high quality product.

13. Responsible for project planning and execution.

14. Overall responsibility for utility operation and maintenance (HVAC, water system, Boiler, DG and Air compressor

15. Overall responsibility for new machine installation IQ, OQ, PQ with requires service qualification.

16. Overall responsibility for all equipment preventive maintenance & breakdown maintenance.

17. Overall responsibility for Calibration & Validation of all equipment.