Quality Assurance Engineer

Engineering Assurance

1. To ensure service floor compliance to cGMP and GDP in technical area/utility area/equipment up keeping.

2. Responsible for implementing company Quality Ethics policy for data integrity and inform management and responsible Data integrity compliance head on any data integrity issues as per corporate Data governance policy.

3. Responsible daily oversight of document destruction process.

4. Responsible for quality oversight of personnel, process and practice to meet the cGMP and compliance requirement.

5. To review electronic records like PLC, SCADA, equipment printouts, audit trails, alarms as per site SOP.

6. To ensure compliance to preventive maintenance/ calibration planner.

7. To verify equipment preventive maintenance checklist and its execution.

8. To supervise Annual maintenance contracts of specified equipment and technical agreement with the service providers.

9. To review SOPs of engineering department and ensure compliance.

10. To verify qualification /validation activities of all Utility systems and continuous performance.

11. To evaluate and comment on change proposals/ deviation and other applicable QMS documents initiated in the area of operation.

12. To review the calibration records of equipment/instrument (other than QC).

13. To review maintenance requests and ensure the completeness with respect to compliance.

14. To verify the daily logs of, AHU/HVAC, Water system, Dust collector, Compressed air''.

15. To review the filter replacements records and filter cleaning records.

16. To review the Data logger’s calibration certificates of storage area of warehouse.

17. To review calibration records of standards weights calibrated by outside party of balances of Engineering and Warehouse.

18. To review SOPs of engineering department and ensure compliance.

19. To ensure compliance to preventive maintenance/ calibration planner.

20. To ensure compliance to Filter cleaning schedule and HEPA Filter Qualification Planner.

21. To verify qualification /validation activities of all Utility systems.

22. To verify the effectiveness of change control and CAPA implementation in Engineering.

23. To participate in investigation of deviations and incidents in Engineering.

24. To review and manage the User Access Management of Utility and warehouse equipment.