รายละเอียดงาน**Main duties, responsibilities, and authorities (หน้าที่, ความรับผิดชอบและอำนาจ):
-Responsible to monitor all activities carried out related to product quality.
-Deliver solution to product sustaining issue.
-Responsible for Data analysis
-Handling of test batch request for the new processes and for trouble shooting.
-Gap analysis of QA related documents.
-Responsible for in process Quality checks
-Installation and calibration of machines and trouble shooting
-Preparation of process validation protocols and reports
-Raise CDCR/Change control for implementation of Quality processes
-Responsible for collecting data for PMS and prepare PMS report
-Responsible for preparing PMS report
-Responsible for preparing design file
-Responsible to prepare IVR report
-Responsible to conduct outside testing as per requirement
-Responsible to optimize the process as per requirement
-Responsible for testing of evaluation piece as per requirement
-Responsible for communication with outside laboratory as per requirement
-Responsible for training of employ for rejection control and other GMP training.
**Authority
-Authorized to Check In process and Finished product Quality of any department
-Authorized to raise corrective and preventive action regarding Quality of Product
-Authorized for internal quality audit.