Xavier Chang

QA Vice Supervisor

  New Taipei City, Taiwan

QA Vice Supervisor in Kyowa Kirin Taiwan Co., Ltd.

 

Work Experience

品保主任  •  台灣協和麒麟股份有限公司

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:
●教育訓練:提供同仁最新相關法規與SOP修訂程序之訓練;
●異常事項(含偏差與缺失)處理:記錄並處理非預期或偏差/缺失事件;
●自我查核:檢查與檢討過去執行之日常作業並計劃改進;
●矯正及預防措施(CAPA)計劃與執行:計畫並執行異常事項之改正及預防;
●變更管制:記錄與執行影響產品及公司營運之變更;
●品質風險管理:事前針對重大決策評估其風險並計劃對應措施;
●年度品質檢討:定期檢討品質面政策與執行成果;
●進口貨物運送安排、放行判定、與庫存管理:聯繫報關行安排進口並依適用法規、SOP、產品核准規格放行產品至市面,及執行後續的庫存產品管理以避免缺貨;
●退回品處理:將客戶端退回產品進行判定與安排銷毀;
●客戶怨訴/偽禁藥處理:記錄客戶端回報之問題、並於必要時擬定CAPA;
●委外物流廠的PIC/S GMP/GDP管理與查核:對委外作業進行委託前及期間之評估;
●供應鏈與庫存管理:與供應商/原廠溝通以避免缺貨或過剩之情形;
●藥物回收:安排並指導同仁將偏差、OOS產品從市面上回收(曾負責處理實際回收3次,包含1次全面性回收);
●GDP許可申請與展延:依TFDA公告及最新法規申請與展延公司的GDP許可;
●集團全球性品保會議:依集團規定每年1至2次出差至日本、英國等總部參與全球性品保會議,討論各國藥業法規更新與應對程序;
●包材申請前覆核與文本翻譯:於包材(包含外盒設計及仿單)初次申請及變更申請前執行覆核其正確性、並執行必要的翻譯;
●擔任藥品安全性(PV)職務代理人協助CIOMS form的通報。

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.

Education

2010 - 2014

長庚大學

生物醫學

Skills

User Experience


  • User testing
  • Web usability

Product


  • Competitor analysis
  • Business research

Language


  • Chinese
  • English
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