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Quality Assurance for Pharmaceutical, Medical Device, and Cosmetics field.

長庚大學

QA/PV Specialist

Hong-Yi Chang

Galderma

台灣台北市

協助藥品廠商（依據PIC/S GMP與GDP）及醫療器材廠商（依據ISO 13485及GDP）建立品質管理系統，包含硬體（例如倉儲設備配置與溫度測繪）、軟體（例如SOP及人事組織、流程設置），以及處理廠商產品之查驗登記（Regulatory Affairs; RA）事務（包含醫療器材QSD登記），並於公司內作為管理職管理2位下屬之專案執行進度、以及與規劃公司人事制度。

As a Project Manager to establish the quality management system of pharmaceutical companies (according to PIC/S GMP & GDP) and medical device companies (according to ISO 13485 and GDP). The tasks includes hardware establishment (such as warehouse equipment setup and temperature mapping), software stipulation (such as SOPs, organization, and operation settings). I also handled regulatory affiars (RA) for pharmaceuticals and medical devices (including QSD application). And besides, as a manager, I manages 2 subordinates for project progress, and set up personnel rules within the company.

斐然國際事業有限公司

專案經理

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.

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