「『保瑞-中壢廠』QE Associate」的相似工作
(保瑞藥業)Bora Pharmaceutical Laboratories Inc._益邦製藥股份有限公司共500筆
10/20
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.
10/20
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。
10/17
• 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
10/20
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。
10/22
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.
10/16
普瑞默生物科技股份有限公司生化科技研發業
【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》
10/23
台灣東洋藥品工業股份有限公司藥品製造業
1. 原料、半成品、最終成品及安定性試驗之理化試驗。
2. 標準流程書編撰及審閱。
3. 安定性計畫書編寫。
4. 理化實驗試劑、試液、試驗樣品、標準品、分析器具及留樣品等維護管理
5. 協助指導課內人員檢驗相關問題及新進人員的教育培訓。
10/02
祥翊製藥股份有限公司藥品製造業
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
10/24
BORA PHARMACEUTICALS CO., LTD._保瑞藥業股份有限公司藥品／化妝品及清潔用品批發業
**此職位上班地點為保瑞藥業中壢廠，交通方便
**面試提問主軸包含國外主管機關驗廠實例 (FDA)，非常歡迎具製藥/生技/醫材業背景人選!
Job Summary:
1.Provide QA oversight CDMO Projects and Site compliance activities with quality oversight for commercial batches.
2.Achieve QA department goals and company objectives.
Job Duties and Responsibilities:
1.CDMO Projects - Quality oversight on quality activities including review and approve documentation, change controls for trial/submission batches.
2.Supplier Management - Manages Supplier Qualification, Audit program and Approved Supplier List
3.Audit Management - Manages internal and external audit activities, reviews and supports site audit readiness strategy, oversees preparedness for audits from agency (FDA, TFDA), or external audits from the sponsors/customers, support regulatory actions follow-ups on audit non-conformance resolutions and CAPA follow-ups.
4.To provide oversight for site self-inspection programs and implement continuous improvement initiatives.
5.Management of Quality Assurance Agreements (QAAs) – Establish and ensure current QAAs is up-to-date to support CDMO operations.
6.Site Score cards Management – Coordinate and report site quality metrics and organize quality councils
7.Oversight on annual CGMPs refresher training, coordinate periodic GEMBA walks and support site QIP programs to ensure site compliant to current FDA CFRs, TFDA regulations and customers requirement per Quality Assurance Agreements established for CDMO activities
8.Ensure personnel training/ qualification and curriculum are aligned to job roles and responsibilities
9.Others: Any additional assignment requested by Supervisor.
10/21
懷特生技新藥股份有限公司生化科技研發業
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
10/21
10/21
藝珂人事顧問股份有限公司人力仲介代徵
"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!
10/20
1.Perform process validation in accordance with company and regulatory requirements.
2.Prepare and revise production Master Batch Record for process validation and commercial.
3.Execute manufacturing process.
4.Prepare data summary and reports.
5.Other duties as assigned, such as shipping study, bulk hold study, and packaging validation.
10/14
祥翊製藥股份有限公司藥品製造業
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。
10/17
華城電機股份有限公司電力機械器材製造修配業
1. 執行與查核環保法規。
2. 督導與協調各單位執行環保業務，環保巡查，辦理相關教育訓練。
3. 執行環保業務(如申報、化學品管理、許可證申請、專責人員提報...)。
4. 執行ESG、ISO 14001、ISO 14064、ISO 50001相關管理系統等業務。
5. 上級主管交辦事項。
*具相關經驗者優先面試。
10/22
健喬信元醫藥生技股份有限公司藥品製造業
We are seeking a highly motivated and innovative R&D Scientist to join our pharmaceutical development team. The successful candidate will contribute to the design, formulation, development, and optimization of drug products, with a focus on quality, scalability, and regulatory compliance. This role offers the opportunity to work in a collaborative environment with cross-functional teams including Regulatory, Analytical/QC, Quality, Manufacturing, and Business Development.
1.Conduct research and development of new drug formulations for Global Regulated markets (Nasal – Solution, Spray, DPI, pMDI etc.)
2.Follow Quality by Design to plan & execute lab-scale experiments, stability studies, and process development activities including DOE.
3.Responsible for managing monographs, validated excel sheets, approved reports (paper and electronic), notebooks and document archival.
4.Develop & optimize manufacturing processes in compliance with cGMP requirements.
5.Participate in Technology transfer to manufacture pilot, scale up, submission & commercial batches.
6.Prepare technical documents, as per cGMP & ICH for execution and manufacturing including batch records, protocols and reports.
7.Prepare regulatory submission documents as pe ICH including chemistry manufacturing & controls (CMC), product development report, overall quality summary (OQS) etc.
8.Execute CCR, deviation investigation, CAPA, LIR, SOP preparation, internal and support GMP inspection.
9.Stay updated with scientific & global regulatory advancements and ensure knowledge sharing with co-workers.
10.Collaborate with cross-functional teams on project timelines and deliverables
10/20
台耀化學股份有限公司藥品製造業
1. 協助工程人員之工程執行的相關文件(DV/IQ/OQ/PQ/RQ、設備流程圖、廠區配置圖及協助相關SOP之修正或建立等)之文書作業申請/處理/跟催/追蹤/彙整/統計及歸檔作業完成
2. 協助維護VP、IA與RA文件
3. 協助SOP制定或修改之相關文書作業與會簽進度的追蹤及跟催
4. 負責Trackwise相關文件資料key in與處理、追蹤及跟催CCR之進度與結案完成
5. 負責廠內SOP/3Q/內訓/外訓及進度跟催與追蹤
6. 負責協助查廠相關事宜
7. 主管交辦事項
10/21
金車股份有限公司飲料製造業
1.品管相關檢驗、測試、試車。
2. 需配合工作加班。
3.食品、化學相關科系佳。
4.加班費另計。
5.其他主管交辦事項。
6.歡迎應屆畢業生應徵。
10/20
•Drive talent management processes including workforce planning, onboarding of new hires performance management and talent development program.
•Support employee relations by addressing employee concerns, conducting investigations, and facilitating conflict resolution.
•Collaborate with HR Centers of Excellence (e.g., Learning & Development, Talent Acquisition, Compensation, Payroll) to deliver integrated HR solutions.
•Supporting change management initiatives and organizational development efforts.
•Administer employee performance review programs, providing guidance to managers and employees.
•Provide guidance and support on employee relations issues, conflict resolution, and disciplinary actions.
•Ensure compliance with labor laws and company policies within assigned business units.
•Maintain and update HR records, employee files, and HRIS systems.
•Assist with benefits administration and open enrollment processes.
•Coordinate training and development programs to support employee growth.
•Collaborate with management to develop and implement HR policies and procedures.
•Support employee attendance tracking.
•Participate in HR projects and initiatives as needed to improve HR service delivery.
10/20
霖揚生技製藥股份有限公司藥品製造業
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。