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.