New Taipei City, Taiwan
June 2016 - September 2020
於2016年6月加入台灣協和麒麟股份有限公司日系藥商，自見習專員擔任起直至品保副主任，作為權責人員（Responsible Person; RP）獨立負責執行品保（Quality Assurance; QA）、PIC/S GMP/GDP相關的文件化作業（SOP與表單）及維持品質管理系統的運作，內容包含：
In June 2016, I joined Kyowa Kirin Taiwan Co., Ltd. as an intern Specialist at first to as a QA Vice Supervisor. My responsibilities are independently handling and the maintenance of documented procedures (SOP and records) regarding Quality Assurance (QA), PIC/S GMP/GDP as the responsible person (RP), including:
●Training: Provides colleagues knowledge of latest regulation and SOP revisions.
●Irregularities (including deviations and deficiencies) Management: Records and handles unexpected or deviated issues.
●Self-inspection: Examines and reviews past activities and plans improvements.
●Corrective Actions & Preventive Actions (CAPA) plan and performance: Plans and performs corrections and preventions to irregularities.
●Change Control: Records and performs change impacting products and procedures of the Company.
●Quality Risk Management: Priorly evaluates and plans relevant actions toward significant decisions.
●Annual Quality Review: Regularly reviews quality policies and the results.
●Transportation Arrangement, Release of Imported Products, and Stock Management: Contacts customs brokers to arrange importation and release the products according to relevant regulations, SOPs, and approved specifications. And manages stock status to prevent out-of-stock.
●Returned Products Handling: Determines and arranges disposal of returned products from customers.
●Customer Complaint/Suspected Falsified Product Handling: Records the problems from customers and plans CAPA when necessary.
●PIC/S GMP and GDP Management and Audit of Outsourced Logistics Company: Evaluates the contractee before and during the outsourced activities.
●Supply chain and stock control: Communicates with suppliers/originators for preventing stock-out or overstock.
●Medicinal Product Recall: Arranges and instructs colleagues for collecting deviated or OOS products from the market (with 3 times actual recall handling experience including 1 time whole-lot recall).
●Application and renewal of GDP approval: Applies and renews GDP approval of the Company according to latest TFDA’s announcements and regulations.
●Global Quality Assurance Committee: Participates in meetings once or twice per year in Headquarters in Japan, England, etc., to discuss regulation updates in other countries and countermeasure in relevant procedures.
●Review and translation of packaging materials prior to submission: Reviews the correctness and translates relevant content of changed packaging materials (including package design and package inserts) before the submission of the first-time application and of change application to TFDA.
●And as the Deputy of Pharmacovigilance (PV) to assist the reporting via CIOMS forms.
2010 - 2014