「【生產營運中心】確效暨委外管理處/確效部(中壢廠)/ (資深)專員」的相似工作

1. HPLC、GC分析方法開發 2. 安定性試驗設計及報告撰寫 3. 撰寫品質文件 4. 執行ISO與GMP相關業務 5. 協助原料、半成品、成品檢驗業務 6. 協助實驗室校正與維護作業

1. To maintain site Laboratory Investigation, Deviation and CAPA Management Systems and perform Track and Trend for deviation & CAPA status and to coordinate deviation investigations related to process during products manufacturing and packaging operations on-site or at CMOs/CPOs. 2. To coordinate Product Quality Complaint investigation/FAR actions and perform Complaint management which involve Track and Trend for complaints status and resolution. 3. To coordinate investigation committee meetings to facilitate discussion to identify impact, root cause(s) in order determine effective CAPAs implementation. 4. To coordinate Annual Product Review reporting activities for the site. 5. To provide support for handling inspection of agency (FDA, TFDA), or external audits from the sponsors/customers. 6. Support SOP revision, daily update of investigation status, quality metrics collection. 7. Other tasks as assigned by the company.

1.進行原料及成品檢驗之工作 2.執行產品安定性試驗 3.儀器設備驗證與校正作業 4.檢驗方法修訂、撰寫 5.主管交辦事項

【主要工作內容】 (一)GMP合規之放射性藥品生產（國際級高防護與高氣密性設備）。 (二)GMP合規之放射性藥品之無菌充填（獨特台灣專利鎢罐保護）。 (三)生產設備及儀器維護保養。 (四)生產記錄報表製作與分析。 (五)撰寫工作相關SOP。 (六)其他主管交辦事項。 ※工作須提重物（10公斤） 【加分項目】若您同時具備以下條件很加分。 (一)具藥廠或無菌製劑經驗尤佳。 (二)具二年以上化學實驗或有機合成相關經驗尤佳。 (三)具「輻射安全證書」尤佳。 (四)具「輻防相關證書」尤佳。 (五)放射線相關科系畢業者尤佳。 【專有的工作津貼與獎金項目】 (一)依工作時間計有夜班津貼。 (二)因應公司發展，執行並完成特別專案則另計專案獎金。 (三)「輻射安全證書」證照加給。 (四)「輻防相關證書」證照加給。 ※普瑞默為與國際知名公司合作建置之藥廠，且有專業輻防團隊駐廠指導，能全方位保障所有同仁輻防安全，我們非常歡迎並期待具備相關經驗或有興趣參與台灣核醫製造的您投遞履歷表，讓我們有機會一起聊聊，以尋求彼此合作的機會。 《加入普瑞默生技，與我們一起挑戰世界》

1. Establish a stability database for annual product reviews and product attribute statistics. 2. Stability program management 3. Supplier qualification, internal audits 4. Monitor and implement cross-contamination prevention measures 5. Cleaning validation and verification management 6. Assign as requested by supervisor. 該員工主要負責APR (stability section), Stability program management, shipping study

1. 研擬審藥典與食品相關產品資料蒐集、匯整與分析測試的規格建立 2. 熟悉化學／化工原理，與操作化學檢測儀器及檢驗報告結果判讀 3. 開發調整分析方法(HPLC, GC, IC...)，協助產品製程開發過程中，分析方法之確校。 4. 主管交辦事項 ーーーーーーーーーーーーーーーーーーー *熟悉多醣分析相關研究為優先* 勇於接受工作挑戰，能隨公司變革腳步而做應變的人 抗壓性強，能展現績優的執行力 注重團隊合作

• Perform assigned QC work, including routine and non- routine, independently The non-routine work may include method transfer/verificati on/ validation , protocol driven study, or investigations. • Trouble-shooting capability for QC technologies . • Assist in reviewing QC documents including notebooks, datasheets, experimental records, and logbooks • Provide guidance to specialists and lab technicians as assigned • Check the preparations of reagent, volumetric solutions, and test solutions • Perform method verification/ quali ficati on/ validation as required . • Assist in preparing SOP, protocol trai ning, and assigned analytical works

製程管制及取樣、品保記錄維護 1.依不同製程需求執行製程管制活動 2.原物料取樣及檢查 3.純水/自來水水質取樣 4.清潔確認及確效取樣 5.文件紀錄及數據管理 6.其他如主管交付工作任務 7.需視需求配合輪班，週休二日，國定假日休。 8.輪班津貼、加班費另計，提供供餐(午餐)，有員工停車場。

基本應徵條件 1. 有儀器使用經驗，如:化學檢測儀器操作、實驗室設備操作、秤量測定與校正、儀器設備需求分析等 2. 熟悉分析原理及儀器操作，如:Dissolution溶離機、GC、UV光譜儀、IR光譜儀、水份儀、酸鹼值示器(PH meter)、HPLC等分析儀器操作。 方法開發與建立、移轉 1. 進行原物料、成品等分析方法建立及分析方法確認/確效 2. 技轉已建立之分析方法/確效 原料與成品分析 1.依相關規範，配合藥品處方研發過程，執行各階段之原料藥與成品藥的分析化驗 2.制訂撰寫產品分析研發文件與SOP技術文件 實驗室管理與維護 1.依規範進行相關品質訓練 2.定期完成儀器驗證 3.制定撰寫實驗室相關SOP文件

1.藥品,健康食品及保健品等微生物限量檢驗及一般物理檢驗 2.廠區水質分析(含微生物)檢驗 3.藥食品分析設備校正 4.執行藥食品安定性試驗

1. 留樣品/安定性管理。 2. 製造批次審核、COA COC發行。 3. 生產製程中IPC取樣。 4. 產品異物檢查。 5. 其他主管交辦事項。 其他條件 1. 具藥廠QA經驗者優先GMP針劑/固型劑生產製造流程佳。 2. 外語能力聽/說/讀/寫中等或以上，具抗壓性，溝通協調能力。 3. 需要經常進產線更衣。 4. 視力需要配合矯正到公司規定。 5. 熟悉Office操作。

1.西藥原料,半成品,成品化驗（微生物試驗） 2.安定性試驗分析 3.化驗規格及方法維護 4.儀器確效及核驗 5.完成主管交辦事項

1.Assist in Process Validation and Technology Transfer activities to ensure the accomplishment of company goals. 2.Assist in qualification works for production equipment meeting timeline and cGMP requirement. 3.Coordinate feasibility trials and process validation activities. 4.Prepare study plans, and qualification documentations and/ or batch records assigned tasks. 5.Support production related investigation, CAPA and troubleshooting.

1. 負責全廠品質制度之規劃與執行,以確保系統與產品符合國際GMP及PIC/S法規要求。該角色的範圍還包括品質預算和資源規劃、品質績效指標/品質看板、品質策略規劃、品質目標和品質特定項目。 Responsible for planning and implementing the factory quality system to ensure that the system and products comply with international GMP and PIC/S regulations. The scope of this role also includes quality budget and resources planning, quality performance metrics /quality dashboards, quality strategic planning, quality goals& objectives, and quality-specific projects. 2. 品質系統Quality Management System - Oversee Quality Management System (QMS) activities such as customer complaints handling, deviation management, CAPAs, change controls quality risk management, etc. ensuring they are timely and effectively executed. 3. 法規系統Compliance System- Oversee and support supplier quality management program, documentation management, and training management in medical quality. 4. 稽核和查廠Audit and Inspection- Coordinate self-inspections and support regulatory authorities' inspection/client audits. 5. 品質績效指標Quality KPI - Monitor quality-related metrics ensuring their compliance with the site targets and host quality councils. 6. 跨部門活動/專案管理Cross-function activities/projects- Support cross-function activities/projects when required ensuring quality regulations and requirements are followed. 7. 主管交辦事項Assigned by supervisor

Introduction to the job Do you like challenges and do you want to work in a fast pacing supply chain environment to support some of the biggest semiconductor companies worldwide? Are you familiar with Logistics Operations and like to managing urgent demands on a daily basis?  If this sounds like you and if you have a strong customer oriented mindset, here is your mission. Role and responsibilities For our Global Operations Center in Taiwan we are searching for Supply Chain Professionals. You fulfill the demand of our customers for spare parts and tools for their maintenance activities on some of the most complex machines in the right quantity and at the right time & cost. Time is of the essence to ensure a seamless production of our customers without interruptions on our machines. -Handling of urgent material requests from worldwide customers in a rolling 24/7 shift system with the right customer focus, while meeting all milestones related to communication and execution -Monitoring of worldwide shipments  -Ability to resolve complex issues and drive improvements to further optimize processes -Ability to support escalations and provide communication proposals for review -Constructive and reliable communication with worldwide stakeholders from all departments within ASML -This position requires shift work. Education and Experience Bachelor's Degree in related subject i.e. Supply Chain Management, Information Science, Engineering etc. preferred -Minimum 1 year of relevant experience in an international company, semiconductor industry is preferred -A tactical thinker with strong interpersonal and communication skills -Analytical thinking and ability to organize and prioritize workload Skills Working at the cutting edge of tech, you’ll always have new challenges and new problems to solve – and working together is the only way to do that. You won’t work in a silo. Instead, you’ll be part of a creative, dynamic work environment where you’ll collaborate with supportive colleagues.  There is always space for creative and unique points of view. You’ll have the flexibility and trust to choose how best to tackle tasks and solve problems. To thrive in this job, you’ll need the following skills: -Stress-resistant; act under high pressure -Flexible; willing to go the extra mile for the customer -Excellent professional communication in English, written and oral -Drive for results; does not stop until solution has been found, even when obstacles arise -Team player -Change management competencies -Convincing, pro-active and “can do” mentality -Cultural awareness -Experience with ERP system(s), SAP R/3 knowledge preferred -Ability to prioritize Diversity and inclusion ASML is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, veteran status, disability, sexual orientation, or gender identity. We recognize that diversity and inclusion is a driving force in the success of our company. Need to know more about applying for a job at ASML? Read our frequently asked questions.

Dealing with work related to quality and compliance. 1. Responsible for the follow-up on the corrective and preventive action of deviation report, CAPA form, complaint, internal audit. 2. Assist in the maintenance of the Risk Management and files regarding Quality Deviation/Change Control. 3. Responsible for regional KPI reporting. 4. Perform calibration activities, such as perform calibration/ validation and raise report. 5. Perform temperature mapping activities 6. Oversees warehouse temperature profile, van temperature record, pest control, facility maintenance monitoring. 7. Responsible for preparing validation protocol and summary report. 8. Assignment will be subject to management decision based on department needs. 作業地點有兩個倉庫 (1)高上倉:楊梅區高上路一段150號 (2)龍潭倉:楊梅區梅獅路二段629號 Welcome to submit your application through the DKSH career website. We encourage candidates to submit your resume through the DKSH Career Website and talk with Genie. Applicants who apply via this channel will be given priority in the interview process. 歡迎透過DKSH招募網站投遞履歷 我們鼓勵應徵者透過 DKSH 招募網站提交履歷，並與 Genie 聯絡。透過此管道申請的候選人將在面試流程中獲得優先考量。 https://jobs.dksh.com/job-invite/214547/

1. 管理清淨室環境監控採樣、檢測 2. 管理水系統採樣、檢測 3. 協助微生物樣品檢驗及報告審閱 4. 協助OOS調查以及相關探究性試驗及再驗 5. 協助管理微生物實驗室環境之維護 6. 協助撰寫SOP、計劃書 (清淨室及水系統相關) 7. 完成上級臨時交辦事項

1. 客戶GMP稽核/衛生主管機關GMP稽核：稽核前，協調各部門，依稽核議程準備稽核所需之文件資料；稽核時，瞭解稽核員之問題及要求，調度整合提供內部文件資料，以利應對人員答詢；稽核後，依稽核缺失內容，協調及追踪權責單位提供回覆之文件資料。 （台耀化學為國際化之藥廠，客戶大多為國外大廠（美、歐、英、日、韓、印度、巴西等），稽核業務提供許多與國外客戶接觸之機會，並可實務練習及應用英文之聽說讀寫） 2. 內部稽核：建立公司之內部GMP稽核年度計劃，並協調組成內部稽核小組，依計劃完成各部門之稽核。 3. 作為台耀與衛生福利部食品藥物管理署監管組之窗口，對GMP核定事項有變更時，完成報備業務 4. 負責與課內業務有關之SOP、文件制修訂

"國際製藥大廠，穩定發展，正職獵才機會" 將支援公司品質保證與品質控制相關作業，工作橫跨實驗室操作、 品質系統管理、供應商與倉儲管控，是企業品質穩定運作的核心角色!!! 工作內容: 1.具備西藥製藥廠 QC 主管經驗。 2.綜理原料藥、成品檢驗、水系統及環境監測之執行與確效，並負責 COA 準備。 3.QC SOP 撰寫與更新，OOS 與 Deviation 事件調查，以及 CAPA 擬定與追蹤改善。 4.具備實驗室儀器操作經驗，熟悉 PIC/S GMP 規範。 福利制度: 1.優於法令的年度健檢，專業醫護及免費心理諮詢，全面守護身心。 2. 豐富的CSR公益活動、家庭日、員工旅遊、春酒/尾牙，樂趣無限。 3.免費機車停車位，中壢工業區稀有免費汽車停車位（每年抽籤）。 4.全額補助海外研修，前往日本、越南、韓國、西班牙等地，拓展全球視野。 若您對品質把關有熱忱，並具備實驗室操作與紀律執行力， 這將是您在國際藥廠職涯邁進的重要一步！ 也歡迎更多Q高階主管投遞詢問，若有合適職務也會同步分享給您!

1. 固形劑半成品、成品理化檢驗。 2. 注射劑半成品、成品理化檢驗。 3. 產品安定性作業檢驗。 4. 主管交辦事項。