Quality Engineer

1. Train and supervise QA Technicians on validation activities and execution. 2. Perform IQ, OQ, PQ and process validation during the installation of new production equipment or as directed by change control procedure. 3. Responsible for equipment registration for new equipment and to maintain the equipment master list. 4. Responsible to conduct Process Validation and Cleaning Validation including preparation of documents, execution and compilation of validation data. 5. Assist in troubleshooting quality problems using the FMEA or similar tools. 6. Assist in performing risk analysis and providing proposals for the elimination or reduction of risks. 7. Responsible for supervising the monitoring of the manufacturing environment and utilities according to fixed schedule or when needed. 8. Plan and supervise the monitoring of Clean rooms, clean air devices, prepare protocols, review the data and prepare the reports. 9. Plan and supervise monitoring of manufacturing environments during the Start-up and Shutdown activities. 10. Responsible for initiating the in-house calibration request of monitoring and measuring devices used in Quality Assurance Department. 11. Responsible for monitoring and scheduling third party calibration of all Clean Air Device and Clean room Performance Test. 12. Ensure all activities are properly recorded and promptly documented and to comply with GMP and ISO requirements. 13. To work towards to achieve department KPI and provide support in internal audit, external audit and continual improvement plan. 14. Participate in any activities pertaining to training, safety, first-aid and fire-fighting organized by the company for the benefits of the staff and the company.