รายละเอียดงานResponsibility:
Essential duties:
1)Responsible to conduct and prepare report for the internal quality audit (IQA) as part of IQA team
member, and daily inspection to monitor the compliance to cGMP.
2)Follows-up the correction and CA/PA obtaining from the Internal quality audit (IQA),
Nonconforming products, Corrective Action Request (CAR), Improvement Report, Customer complaint, and then reports to QA Department Manager.
Related duties:
1)Develops, analyzes and summarizes cGMP technical/ validation documentations, e.g.,
Organization validation structure and validation master plan (VMP) by working closely with Manufacturing , Quality Assurance, Quality control, Productivity Supporting and Regulatory Affair division.
2) Maintain appropriate validation documentations, as well as, coordinate for investigation of validation troubleshoot problems and determine solutions.