- To ensure service floor compliance to cGMP and GDP in technical area/utility area/equipment up keeping.
- 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.
- Responsible daily oversight of document destruction process.
- Responsible for quality oversight of personnel, process and practice to meet the cGMP and compliance requirement.
- To review electronic records like PLC, SCADA, equipment printouts, audit trails, alarms as per site SOP.
- To ensure compliance to preventive maintenance/ calibration planner.
- To verify equipment preventive maintenance checklist and its execution.
- To supervise Annual maintenance contracts of specified equipment and technical agreement with the service providers.
- To review SOPs of engineering department and ensure compliance.
- To verify qualification /validation activities of all Utility systems and continuous performance.
- To evaluate and comment on change proposals/ deviation and other applicable QMS documents initiated in the area of operation.
- To review the calibration records of equipment/instrument (other than QC).
- To review maintenance requests and ensure the completeness with respect to compliance.
- To verify the daily logs of, AHU/HVAC, Water system, Dust collector, Compressed air''.
- To review the filter replacements records and filter cleaning records.
- To review the Data logger’s calibration certificates of storage area of warehouse.
- To review calibration records of standards weights calibrated by outside party of balances of Engineering and Warehouse.
- To review SOPs of engineering department and ensure compliance.
- To ensure compliance to preventive maintenance/ calibration planner.
- To ensure compliance to Filter cleaning schedule and HEPA Filter Qualification Planner.
- To verify qualification /validation activities of all Utility systems.
- To verify the effectiveness of change control and CAPA implementation in Engineering.
- To participate in investigation of deviations and incidents in Engineering.
- To review and manage the User Access Management of Utility and warehouse equipment.