Research Assistant
Taiwan Food & Drug Administration
Total des années d'expérience :26 years, 6 Mois
To assist and review medicinal production management and regulatory research . To implement the scientific development plan for medicinal production.
Reported directly to the chief of Health Inspection.
To investigate the stock of foods, drugs, cosmetics, quality, label and other illegal advertising and inspect drug manufacturers, pharmacies, pharmacy staff, registered dietitian nutritionists in Taiwan.
Responsible the communicating and coordinating of medical devices and cosmetics to industrial policy and prepare memorandum of understanding with US and EU for medicine cooperation in medical devices section.
Achievement: Accomplishing a signature for diplomatic agreement for recognition of Taiwan authority medical device certification to Department of Health of the United Kingdom.
Promote and assist medical device policy to local medical device manufacturer, such as cooperated with Center For Drug Evaluation (CDE) staff to assess innovation and new concept medical device company in Taiwan.
Reported directly to the vice general manager and QA manager
Responsible the establishing and improving of quality management system to ISO 13485 and prepare GMP concepts for plants, systems in the device medical sector, design and prepare validation process to facilities and instrument both production and laboratory, cooperate and communicate cross departments.
Achievement: Strengthen quality management system for customer auditing and local authority assessment periodically, especially set up corrective and preventive action, change management, out of specification (OOS) and deviation management and customer complaint for QSR, ISO13485 and Taiwan GMP.
Responsible the writing of SOP quality management and guide material personnel and operators to production flow, housekeeping based on 5S activity, cooperate and communicate cross departments, and deviation improvement.
Achievement: Assist and implement specific cGMP about auditing, review batch production record, oversee production process and facility.
Responsible for the establishment of ISO 9000:2000 and ISO 9000-3:1997. Follow Taiwan High Speed Railway contract.
Achievement: Established a quality assurance system with consult company.
Solely responsible for defining SOP, the project of validation by FDA, ISO 9000 training, approval of Cleaning Log Sheets for GMP
equipment and the implementation of ISO Audit System in Production Department.
Achievement: Enhance quality concept of GMP and ISO for production department and join a genetic drug from R&D transferring pilot plant and production process for scale up.
Responsible for the auditing of ISO 9001 and ISO 14001.
A member of Merck-Kanto’s SHE committee.
Achievement: Established new quality management system without consult company and transferred standard of procedure for quality control and production processing from German mother company.
Cost accounting
Profit & Lose (P&L) repeats
Business accounting for Agfa marketing in Taiwan
Involved in SOP implementation, facility management and lab
analysis
Trained as Industrial Chemist by the Training Center, worked in acryl operation, ethyl acid operation, bisulphate hydrochloric acid operation, central milling unit, hostalen granulation and plant rotection formulation.
Achievement: Learning the German chemical engineering is something that I find to be very rewarding to me and earned a technical chemical engineering certificate from German government.