Licensed Pharmacist in Japan, experiences in Hospital and Pharmacy Store as a pharmacist before graduation from master degree. 3 years experience in dosage form developing and tech trasfer of OSD products and build new OSD manufacturing facility (from warehouse operation, dispensary, granulation, tableting, flim coating, printing and packaging). 2 years experience in bulding supply chain network in Asia Pasific area with expertise of packaging process and regulatory in Asia Pacific zone and US/EU/JP etc.. 4 years experience in Quality Assuarance unit, managing FDA inspection readiness and resnponse to FDA483 and handling warning letter given to CMO, implement remediation work in Japan with US quqlity consultants include sterile assurance improvement and of sterile manufacturing improvements to meet FDA requirements (cGMP). 2 years experience in building business process redesgin project with exerience in SAP ERP system, especially SAP-QM module and other Quality IT systems (LIMS, EQMS, LMS, DMS).3 years experience in inspection management, performing self-inspection, and supplier management and a certified lead auditor.