• 面議(經常性薪資達4萬元或以上) 台北市信義區 2年工作經驗 3天前更新
    - Evaluation of submission feasibility for in-licensed products (major) and domestically manufactured products in the APAC region (South Korea, Taiwan, Hongkong, Thailand, Singapore, Malaysia, Vietnam, Philippines, and Indonesia) - Conduction of the dossier audit and production of the gap list - Evaluation and plan of the design, the budget, and the timeline for the bioequivalence study, the bridging study, and the clinical study in South Korea and Taiwan - Communication with the APAC regulatory team and partner company to resolve the submission gap in the target market - Design and consolidation of the regulatory strategy of the key milestone, the submission pathway, the submission timeline, and the launch timeline in the target market - Support of new submissions in Taiwan - Dossier Compliance from CTD format to ASEAN format - Update of the APAC regulations - The other tasks
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  • 面議(經常性薪資達4萬元或以上) 台北市信義區 8年工作經驗 3天前更新
    1. Plan and execute internal audits and special projects to evaluate the risks and the effectiveness of related controls. 2. Prepare reports for each engagement and communicate audit observations with corporate, regional, and local management. Apply problem solving skills to issues and provide practical and constructive recommendations. 3. Develop credibility and trust with operating functions to value-add internal controls and management. 4. Monitor changes in Company policies and procedures to align with the applicable Regulations, Standards, and industry practices.
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  • 面議(經常性薪資達4萬元或以上) 台北市信義區 6年工作經驗 4天前更新
    1. Support and facilitate business user‘s requirement to seamlessly running at corporate SAP system(SD, MM or PP module) in the landscape via analyzing, designing, and developing. 2. Work closely with the team (other SAP developers, infrastructure & system teammates) to understand business needs and deliver features in good quality at timely manner. 3. Be capable of creating and assessing software architecture/designs with multiple stakeholders. 4. Manage overall change request and/or incident backlog for the owned topics and ensure the high quality of corrections and notes for the owned topic areas and of stable assist packages with no regressions. 5. Exhibit learning agility by quickly upskilling on new tasks and concepts. 6. Assist our business users during product deployment, critical operations, and system rollout via standard infrastructure, creating maintenance notes and documentation. 7. Will be providing presentations and workshops.
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  • 面議(經常性薪資達4萬元或以上) 南投縣南投市 工作經歷不拘 4天前更新
    1.開發調整分析方法(HPLC, GC, IC...),協助產品製程開發,分析方法之確校 2.執行實驗室設備3Q 3.研擬審查藥典相關產品規格及分析測試,建立藥典規格 4.操作化學分析儀器進行分析,協助產品放行
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  • 面議(經常性薪資達4萬元或以上) 南投縣南投市 5年工作經驗 4天前更新
    1. Responsible for new projects feasibility evaluation and map out the submission strategy for global. Evaluate the product information, lead the discussion with the local RA team to find out the possible submission pathway. 2. Ensure timely new product submission and approvals. 3. Requires well communication skill as a coordinator for Brand Acquisition project between supplier and local RA. Work closely with cross functional team to ensure on-time submission. 4. Monitor the current global submission status and consolidate the submission and approval numbers for management meeting. Specific duties and responsibilities. 5. Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy. 6. Submission and variation experiences in US, EU, APAC markets is a plus. Should handle variation requirement collection, variation strategy evaluation, CMC documents review and variation pack preparation. 7. USFDA Annual report preparation, drug listing, other routine work for US license maintain. 8. Prepare dossier for APAC project submission and modify for ROW submission. 9. Support on the clinical part review, with the help from CRO for APAC project. 10. Responsible for dossier audit for in-license products, and prepare the technical audit report.
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  • 面議(經常性薪資達4萬元或以上) 南投縣南投市 5年工作經驗 4天前更新
    1. Develop analytical methods, perform analytical tests, and assist the RD team in screening formulations for the NDA and ANDA drug development. 制定分析方法,進行分析測試,並協助RD團隊篩選用於NDA和ANDA藥物開發的製劑。 2. Follow laboratory SOPs and ensure GMP compliance. 遵循實驗室SOPs並確保符合GMP規範 3. Prepare technical documents and review data for the R&D projects and drug submission. 為研發專案和藥物開發準備技術文件並審查數據 4. Responsible for performing the R&D tasks and projects, such as analytical method development, method validation, formulation screening, raw material tests, finished product release, stability study, and dissolution testing.負責執行研發任務及專案,例如分析方法開發、方法確效、配方篩選,原料測試、成品放行、安定性研究和溶出度測試。 5. Use and maintain analytical instruments, GC, HPLC, UPLC, Dissolution Tester, Titrator, Particle size analyzer, etc. Research, diagnose, troubleshoot, and identify solutions to resolve analytical instrument issues. 使用和維護分析儀器,GC,HPLC,UPLC,溶出度測試儀,滴定儀,粒徑分析儀等。研究,診斷,故障排除和識別解決方案以解決分析儀器問題。 6. Train, lead, and supervise junior analysts in day-to-day laboratory operations. Support relevant departments and vendors to complete projects on time, ensure the work and analysis comply with GMP and SOPs. 訓練、領導並監督日常實驗室操作中的初級分析師。協助相關部門和供應商按時完成專案,確保工作和分析符合GMP和SOPs。 7. Review documents, prepare the analytical study report and CMC documents 審查文件,準備分析研究報和CMC文件 8. Responsible for establishing, maintaining, and updating the specifications and test methods for in-process and finished products in the pre-approval phase. 負責核准前半成品和成品試驗相關之檢驗方法與規格之制定、維護與更新。 9. Support assigned responsibilities to maintain GMP compliance of the chemical laboratory, as applicable. 依據分配責任,維持化學實驗室運作皆符合GMP規範 10. Promptly complete work and tasks assigned by superior 及時完成上級下達的工作和任務。 11. Support for analytical method transfer to analytical control, QP sites, and other receiving laboratories. 協助將分析方法轉移到分析控制,QP所在地和其他接收實驗室。 12. Cooperating with PD & RA, complete and all lab tests. 配合PD及RA完成各項化驗項目。 13. Ensure analysis can be conducted with efficiency and completed on time 確保分析工作得以高效率及迅速之進行。 14. Managing and maintaining instrument calibrations, laboratory instrument logbooks, and SOPs. 各儀器設備SOP之制訂、管理、定期維護、校正如期完成。 15. Ensure lab work is conducted according to SOP and complies with EU, US, JP, and global cGMP regulations. 確保其實驗操作皆依照SOP進行,並符合歐美日地區及全球cGMP之規定。
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  • 面議(經常性薪資達4萬元或以上) 南投縣南投市 3年工作經驗 4天前更新
    Under minimum supervision, manage site projects from inception through completion. Most of the projects are new product launches, site transfers, and general operations and supply chain initiatives. The project manager is responsible to work proactively with internal parties and possibly third party to achieve timely resolution of identified issues and ensure all project deliverables are completed according to established schedules. He/She is responsible to develop project plans to facilitate successful project completions and to manage and drive project activities including project planning, internal/external communications, project task assignments & follow-up, etc. He/She must also facilitate problem resolution and issue escalation. 1. Establish project plan with project leader, define critical path and milestone till regulatory approval and manage regulatory extension 2. Propose R&D budget for the project, coordinate with Portfolio team for business case preparation and approval 3. Drive execution of the project in a manner that meets delivery performance goals/objectives and the agreed plan without compromising project deliverables or relationships along with Project Leader and implements the Stage Gate systems for good governance. 4. Propose strategies to bring project cost and timeline down with risk mitigation strategy and efficient resource utilization. Present key operational metrics and maintains the Project dashboard on a real time basis 5. Leads team in the preparation, implementation, & maintenance of risk management plans for projects 6. Responsible for ensuring effective, accurate and timely communication of project information
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  • 面議(經常性薪資達4萬元或以上) 南投縣南投市 3年工作經驗 4天前更新
    1. Comply with GMP and EHS regulations 2. Prepare and execute equipment qualification activities which includes design, installation, operational and performance qualification 3. Prepare and execute process validation activities which includes development trials, troubleshooting and monitoring the process validation batches 4. Other responsibility request by line manager.
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  • 月薪44000~48000元 新竹市香山區 工作經歷不拘 3天前更新
    1.訪視農業科技個案產業關係人蒐集彙整產業資訊、成本收益等資料。 2.參與農業科技個案產業應用或市場發展之潛力評估、營運規劃書(business plan)之撰寫、產業關係人之合作鏈結促成,以及推廣活動辦理與推動。 3.協助追蹤農業科技個案計畫執行進度。 4.其他主管交辦事項。 學歷要求: 國內外大學商業及管理學科類、農業經濟相關、生物農業等相關系所碩士畢業。 (薪資待遇:碩士畢業44,280元) 經歷要求: 具備營運規劃書(business plan)撰寫及商務洽談經驗者優先錄取。 職能條件: 1. 良好溝通協調能力。 2. 具小客車駕駛執照。 應徵方式: (一)請利用人力銀行投擲履歷或E-mail:hr@mail.atri.org.tw (合者約談,不合者恕不另行通知) (二)面談時請攜帶下列表件: 1.履歷自傳表。 2.國民身分證正本及影本。 3.最高學歷證件正本及影本。(持外國學歷應加附中文翻譯本及駐外單位驗證之證明)
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    產假產檢假良好升遷制度尾牙員工在職教育訓練
  • 月薪30000~40000元 桃園市平鎮區 工作經歷不拘 4天前更新
    1.原物料、半成品、成品及在製品運輸 2.協助倉庫事務處理 3.環境清潔 4.須具備普通或職業大貨車駕照 中班津貼另計
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    禮品績效獎金生日假意外險員工團保
  • 月薪28000~32000元 高雄市燕巢區 工作經歷不拘 1天前更新
    1.維護日常操作表單紀錄。 2.污廢水系統設備操作保養。 3.例行性巡檢紀錄抄表。 4.污廢水設備故障排除。 5.實地進行環境整頓。 6.安全衛生設施定期檢查並維護之。 7.現場之設備驗收、設定、測試、保養及日常操作。 8.現場水質基本檢測。 9.其他主管交辦事項。
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    年終獎金三節獎金國內旅遊尾牙員工在職教育訓練
  • 月薪32000~38000元 台中市西屯區 1年工作經驗 3天前更新
    產品維修人員,產品售後技術服務 懂電子、電路圖、有維修雷射儀器設備經驗者優先錄取。
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    年節獎金員工生日禮金年終獎金三節獎金績效獎金
  • 月薪32470~37470元 台南市西港區 工作經歷不拘 2天前更新
    1.製造過程中之製程巡檢、實施品管計畫 2.半成品,成品、包裝、出廠之品質檢驗以及判定 3.各項品管圖表之繪製以及標準樣本之製作 4.製程管制,掌握品質變異狀況,解決問題,負責產品品質水準之穩定 5.灌輸作業員品質觀念,教導其使用簡易品管技術 6.不合格品原因之追查、分析、報告以及處理 ★食品科系畢業,需登入衛管人員。 有生技食品廠品管經驗優先錄取。 需熟電腦操作 協助ISO品質系統推行文件管理 微生物培養.檢驗 (如果不會也沒關係) 各式文件管理維護、分類、登記、入檔、保管。 現場品質管理檢測以及與客戶接洽品質或檢測問題 原物料驗收
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    三節獎金禮品勞保健保週休二日
  • 月薪32000元 桃園市新屋區 工作經歷不拘 1天前更新
    公司以健康食品的研發與品管為主要發展項目,歡迎對食品生技醫藥等研發工作有興趣,有天然物經驗者為優先錄取加入團隊,公司可供住宿。
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    產假年節獎金年終獎金三節獎金員工團保
  • 無經驗也能轉職成功,高雄台南+月薪三萬工作機會