「『保瑞-中壢廠』QE Associate」的相似工作

• 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

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. 執行例行性、既有產品之非例行性、以及新產品與新產線之確效 2. 執行產品相關之確效評估或研究測試 3. 制、修訂及維護確效相關SOP 4. 協助審閱各部門確效文件 5. 協助技轉專案之管理 6. 其他主管交辦事項

This vacancy is open for talent pool collection. We will contact you if we have proper vacancies that fit with your profile. Job Mission Represent manufacturing and act as gatekeeper from manufacturing to D&E function Add value in overall manufacturing processes such as forming, machining, joining, and assembling Job Description Contribute to the solution of faults and takes the necessary initiatives and practical decisions to ensure zero repeat Identify gaps and drive assigned process improvement projects and successful delivery Initiate and drive new procedure changes and projects Develop and maintain networks across several functional stakeholders Prioritize works and projects based on business situation Transfer knowledge and train colleagues on existing and newly introduced products Education Master degree in technical domain (e.g. electrical engineering, mechanical engineering, mechatronics) Experience 3-5 years working experience in design engineering Personal skills Show responsibility for the result of work Show proactive attitude and willing to take initiative Drive for continuous improvement Able to think outside of standard processes Able to work independently Able to co-work with different functional stakeholders Able to demonstrate leadership skills Able to work in a multi-disciplinary team within a high tech(proto) environment Able to think and act within general policies across department levels 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.

•Support the project and validation manager in preparing Project Execution Plan and update site Validation Master Plan. •Prepare and implement qualification protocols (IQ, OQ, PQ) used in the production of pharmaceutical products. Where possible, as assigned by the project manager to manage projects related to movement and modification of the manufacturing equipment. •Implement qualification activities, validation protocols, and calibrations in accordance with the needs of the production schedules. •Conduct periodic review of URS/FRS/DDS or DQ to meet the latest regulatory requirements or guidelines from ICH or FDA CFR’s. •Assist in the development and revision of Validation SOPs. •Assist in troubleshooting of equipment and process deviations. •Provide timely and accurate information of validation parameters established for equipment and facilities. •Acts as liaison with Engineering, Technical Service, and Quality Assurance. •Assist engineers/technicians in the development and completion of validation studies and protocols as needed. •Other tasks as assigned by the company.

1. 設定/組裝/拆解/清潔 製程設備：例如混合機、造粒機、打錠機及膠囊充填機。 2. 調製藥品主成分及水溶液。 3. 依據規劃排程執行製造生產。 4. 依據優良製造規範及標準作業程序記錄生產活動於批次記錄。 5. 執行主管交付之其他任務。 6. 需配合輪班，早班:08:00~17:00；晚班:16:00~24:00；夜班:20:00~04:00。 7. 週休二日，國定假日休。 8. 產線獎金、輪班津貼、加班費另計，提供供餐(午餐)，有員工停車場。

*前1~3年工作在「台中廠」培訓，之後開始在「竹北廠」上班。 ●原物料、IPC、產品、安定性樣品、水質之內毒素分析 ●生物活性試驗Bioassay、host cell DNA、host cell protein、sterility等項目例行檢測 (放行檢測、安定性檢測) ●異常事件調查 ●設備維護及校驗執行 ●分析方法SOP制定 ●實驗室LIMS系統 ●其他主管交辦事項

1.品質管理系統: 偏差調查/OOS/OOT、CAPA、變更管制、內外部稽核、客訴管理、人員培訓與資格認證管理 2.供應商管理: 原物料供應商、運輸商、委託合約製造CMO、委託化驗CTL、委託校驗、服務提供者 3.趨勢分析及風險評估 4.產品放行與品質審查 5.設備及設施管理 6.安定性留樣品管理 7.文件管理 8.國內外查驗登記資料彙整 9.執行主管指派的其他任務

1.掌握本廠生產所需之原、材料理化檢驗工作品質與進度,以確保符合生產需求 2.化學實驗室儀器室物件(試劑,試液,試驗樣品,標準品,分析器具)等,各項實驗室內物件整理狀態評估督導 3.執行實驗室異常調查 4. 管理課內所有運作符合PIC/S GPM規範 5. 執行課內人員之選、訓、用、留相關發展與管理

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

哥吉生技致力於開發醣生物學之試劑以用於基礎生科研究與臨床檢測醫材。公司正在尋找具有生醫領域產品開發經驗或品質管理經驗之品保專家，協助建立與管理符合ISO13485之品質管理系統，工作項目包括: 1. 建立與維持品質管理系統，主導品質活動之推行。 2. 與研發團隊合作，訂定品質標準， 協助產品製程相關品質管理與異常處理。 3. 主導內部稽核作業，與品管團隊合作，落實品質水準，確保品質管理系統的有效性。 4. 主導風險管理計畫，協調各部門組成風險管理小組進行風險管理活動。 5. 與法規部門合作，達成品質相關法規與認證合規。 6. 執行內部教育訓練，強化員工對品質系統的認知與遵循。 7. 參與核心決策活動以維持公司品質水準。 資格條件： 合格之應徵者需具有極佳的溝通聆聽與充足的團隊合作經驗，並能靈活運用量化分析。生醫、化學相關科系畢業或有充足的生物化學相關領域工作經驗，並有三年以上於品保品管相關工作經驗。具備建立ISO13485品質管理系統、ISO14971風險管理經驗尤佳。 --- Company Description GlycoGenetics, Inc. is a glycobiology-centric biotechnology company based in Taiwan. Our R&D efforts focus on developing integrated biochemical, cellular, and genetic platforms to understand the complex glycocodes of human biology. We aim to apply glycobiology to address unmet medical needs, offering protein-based glycan-detecting reagents for basic research and clinical diagnosis. Our long-term goal is to address unmet medical needs through new biomarker and therapeutic target discovery. Role Description This is a full-time, on-site role for a Senior Quality Assurance Engineer, located in the Dayuan District, Taoyuan City, Taiwan. This Senior Quality Assurance Engineer will be responsible for assisting our quality management representative in overseeing the overall quality assurance for our protein-based products in compliance to the ISO13485 standard. The role involves managing the QMS and overseeing the quality assurance activities, working with our RA team to meet QMS-related regulatory requirements, working with our R&D team to establish product quality standards, and working with the QC team to ensure the quality and stability of our products through rigorous testing procedures. Qualifications 1. Minimal 3 years of experience in quality-related roles in biotechnology or related industries 2. Experience in ISO quality standard compliance is a strong plus 3. Ability to work collaboratively in a team environment 4. Excellent communication skills to bridge teams of different functions 5. Skills in quantitative analysis 6. Sufficient knowledge in biochemistry or analytical chemistry

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

1. 負責化學藥品、原物料進料檢驗 2. 負責高分子、離子交換樹脂製程中品質檢驗 3. 負責高分子、離子交換樹脂出貨品質檢驗 4. 負責量測設備校驗 5. 製作及維護檢驗品質紀錄 6. 維護統計製程管制(SPC)運作

1.追蹤藥品及醫療器材相關（GMP/GDP/QMS）法規修訂，並協助推動公司法規遵循事項。 2.配合主管機關及客戶政策需求，提供必要資料，並說明公司立場與實際運作流程。 3.執行SOP修訂、紀錄管理及文件變更管制作業，並追蹤各單位教育訓練執行情況與紀錄彙整。 4.與委託商、供應商協調稽核項目、安排實地稽核時程，並執行及追蹤後續缺失改善措施。 5.依據內部稽核年度計畫，協助規劃與執行內部稽核作業。 6.彙整並提供運銷紀錄、品質保證等資料予委託商，供主管機關查核參考。 7.彙整稽核結果與客戶抱怨相關偏差事件，協助執行矯正與預防措施（CAPA）立案、初步調查及追蹤改善。

This position is to maintain cGMP compliance. Primary Duties and Responsibilities, including mental requirements of position: • GMP documents review and approval. • Supervise and conduct supplier qualification program for vendors. • Supervise and conduct in-process, raw material and stability sampling. • Assist QA Management in managing deviation, investigation, CAPA systems, stability program and Quality Systems to comply with applicable regulatory requirements. • Review and create QA-related SOPs. • Miscellaneous tasks assigned by Management.

1.藥物分析方法建立、開發及制度建置。 2.實驗室儀器設備之驗證、保養、維護與改善之計劃擬訂與監督管理，確保設備有效運轉，管制良好，功能正常，量測結果符合品質之要求。 3.熟PIC/S GMP規範。 4.其它主管交辦事項。

1.偏差事情/實驗室調查及矯正預防措施 2.變更管理 3.保留樣品 4.安定性計劃撰寫及執行 5.品質風險管理 6.上市後產品監控 7.其他主管交辦事項

1. 學習染料、助劑在面料染色階段的各種物、化性基礎步驟建立 2. 主管臨時交辦事項等

1、原料、廢棄物、產品及水質檢測。 2、依據環境檢測規範，操作實驗室儀器（ICP、AA、熱卡計、XRF及TCLP等）進行樣品分析。 3、檢測數據計算整理、品質管制值計算及圖表繪製。 4、配合採樣、藥品管理及配製、器皿清洗等實驗室相關工作。 5、與團隊合作，持續優化實驗流程，參與專案研究或新方法開發(提供進修與培訓)。

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