Quality Control Manager
Current2002/05/01 – 2007/05/31 QC Associate Analyst, QC Analyst, QC Sr. AnalystPerform In-Process Control analytical methodologies for moderate complexity projects under general supervision.Perform starting/raw material specification set, analytical method development, method validation and testing. Review the IPC plans, IPC testing results, analytical testing methods, method validation, cleaning analytical methods and reduce of IPC. Coordinated and conducted internal and external audits. Managed QC reference standard.Act as an administrator in QC lab safety activities, like as preparation of safety inspections and attending company’s safety meeting.2007/06/01 – 2013/01 QC Group Leader/ QC Supervisor Performing scientific duties of a high degree of moderate complexity under general direction to achieve the specific goals or function of quality control. Work with QA to oversee the GMP compliance in the department. Take response for the QC working efficiency and accuracy. Review and prepare the submitting of documents about QC part for filing, as well as DMF. Managed technology transfer of several CRO/CMO products. Managed QC technology transfer for outsourcing. Supervised microbiological group for water quality, environment monitor and API microbial testing. Prepared and supported the QC lab for successful internal and external audits with FDA,TGA, PMDA, KFDA, TFDA and EDQM authorities.Coordinate to set up new QC lab. building and moving plan successfully.
