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職缺名稱公司名稱上班地點工作經驗更新薪資待遇
- 面議（經常性薪資達4萬元或以上） 南投縣南投市 1年工作經驗 46天前更新展開
1. 制定/維護/更新使用於研發專案之臨床批及查登批的所有原、物料之規格及化驗方法。 2. 向原料及物料廠商索取相關文件，如：規格與檢驗方法、原料主檔案、技術文件等；審閱3. 廠商提供之技術文件，如有需要，進一步向廠商索取其他文件進行評估，做適當的整理與歸檔。 4. 協助CMC文件準備，提供主成分、賦形劑、包材之檢驗規格予法規部門，使其可進行NDA和ANDA查驗登記的文件整建作業。 5. 審閱B2B差異清單，並準備成本估算、工作計畫，並依據時程制定時間表，並及時協助B2B專案相關的客戶問題的完整回應。 6. 根據B2B需求準備和審核文件，例如檢驗規格、分析方法、標準操作程序等。 7. 按客戶要求準備CMC文件，使其可進行NDA和ANDA查登的文件整建作業。 8. 協助查廠時與實驗室相關之PIC/S GMP文件。 9. 查廠期間支援QA文件調閱與查核。 10. 主導變更管制之撰寫、偏差事件調查、矯正預防措施之評估與執行。定期更新、審閱及維護部門之標準操作程序。 11. 定期更新/採購各主要國家之藥典公定書。 12. 確保所有活動和分析均符合GMP、正確的程序、法規指南以及健康安全法規。
- 面議（經常性薪資達4萬元或以上） 台北市信義區 3年工作經驗 46天前更新展開
Overall Objectives Safety Officer, under the leadership of Lotus PVO (Pharmacovigilance Operations) Head, is responsible for execution of PVO activities in accordance with the Lotus pharmacovigilance quality system and local pharmacovigilance requirements. General Duties • Participates in or conduct daily PVO activities assigned by PVO Head • Maintains an accurate and comprehensive list of the Lotus products which are subject to pharmacovigilance activities by monthly alignment with the Regulatory Affairs teams • Coordinates with Local PV Offices (LPOs), PV CROs and partners or vendors regularly for PV activities • Monitors and tracks the PV activities performed by the stakeholders/LPOs, including, but not limited to: • Screening of local legislation and regulatory safety announcements, screening of local scientific journals for relevant safety information, as required • Maintenance of PV trackers (Individual Case Reports, Medical Inquiry and Product Quality Complaint, Aggregate Report tracker, Risk Management tracker, Safety Data Exchange Agreement tracker) • Updating of PSMF (Pharmacovigilance system master file) and relevant annexes as required • Reviews Individual Case Safety Reports (ICSR) and Medical Inquiries (MIs), as needed • Is aware of the risk management plans approved in their territory and of the risk minimization measures implemented. Assists in ensuring that the required activities are performed and tracked • Assist with the preparation and review of aggregate safety update report (PSUR, PBRER etc.) • Is aware of local safety concerns and supports the signal detection activities by reviewing the outcome of the screening of the local PV legislation and safety announcement, as required • Maintains and files the PV documents filed in the PVO specific folders (hard copy, where required and soft copy) • Coordinates for translation of PV related documents, when required • Tracks received adverse event, MI and PQC. Participates in reconciliation of PV activities between the Local PV Offices (LPOs) and PV CROs or partners or verifies that reconciliation activities are performed as per requirement • Supports in submission of relevant ICSRs received to competent authority within deadline • Participates in regular meetings with PVO and PV CRO as required and in-charge of MOM • Consults PVO Head for any issues or uncertainties relating to pharmacovigilance activities • Communicates with LPOs, PV CRO and other external PV vendors • Informs PVO when contacted regarding agreement involving pharmacovigilance obligations • Supports during audits and inspections • Trains on and applies the Lotus pharmacovigilance SOPs and the applicable PV related regulation • Stays current on the local PV legislation in the Lotus MA countries • Is involved during the development of Lotus pharmacovigilance SOPs • Ensures that all relevant employees in the LPOs receive basic pharmacovigilance training and that training is recorded and archived appropriately • Performs any other PV related activities assigned by the line manager (PVO Head) • Liaise with the stakeholder department or other internal departments.
- 月薪40000元 南投縣草屯鎮 2年工作經驗 46天前更新展開
1. Responsible for the successful delivery of the assigned project in terms of costs, schedule, resources, and quality. 2. Review and validation of the user requirements develop scope of work and follow up of the bid phase. 3. Responsible for project engineering design. procurement technical evaluation conscruction, T&C, and qualification. 4. Collaboration with stakeholders in the capital workflow to ensure the process is followed from: Team Charter. Scope and URS, Schedule, Cost Estamate and CAR submission. 5. Communication to the Site Management: raising awareness if prnblems come up e.g. mil cstones cannot be reached, costs will be higher than planned etc. 6. Manage external and internal resources used in the implementation of capital projects. 7. Responsible for managing the assigned assigned team and resources through a matrix project organization, including contractors and suppliers. Coordinate the team tasks and supervise the right level of deliveries. 8. To execute tasks as delegated by line manager.
- 月薪37800~44280元 新竹市香山區 工作經歷不拘 3天前更新展開
1.協助執行農產品冷鏈計畫亮點成果推動。 2.協助辦理計畫座談活動及科研成果產業化工作。 3.協助蒐整國內外農業、冷鏈物流、採後處理、設備技術及法規等相關資料。 4.協助產業調研分析，工作報告撰寫。 5.執行主管臨時交辦業務。 國內外農業、食品、生技相關系所學士(含)以上畢業。 (依法進用保障名額，具原住民身分尤佳) (薪資待遇：大學畢業37,800元、碩士畢業44,280元) 經歷要求： 1.具政府計畫執行或產業座談活動辦理經驗者佳。 2.熟悉科學研究或產業調查者佳。 3.具辦理行銷推廣活動相關經歷尤佳。 4.熟悉國內外冷鏈物流或農產品採後處理者優先。 職能條件： 1.具備良好溝通協調能力與團隊精神。 2.可配合常出差者。 3.具備基本英文聽說讀寫能力。 4.具備良好文案與文章撰寫能力。 5.熟悉Office Word、Excel、PowerPoint等軟體。 6.具汽車駕照佳。 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）
產假產檢假良好升遷制度尾牙員工在職教育訓練 - 月薪40000元 南投縣草屯鎮 5年工作經驗 46天前更新展開
1. Create, review and maintain asset list and production flow map. 2. Review project initiation sheet, user requirement specification, scope of work. 3. Establish equipment capacity and capability to oversee the utilization 4. Facilitate capital expenditure process flow. 5. Review write-off capital and submit the plan. 6. Facilitate multiple function teams to define project scope and deliverables. 7. Provide technical recommendations for capital projects 8. Create the documentation for training and instruction 10 Accountable for construction safety and regulatory compliance during project execution. 11 Organize appropriate training and transfer of documentation/ information to operation, maintenance team during qualification phase.
- 月薪40000元 南投縣草屯鎮 3年工作經驗 46天前更新展開
Responsible for the packaging site cGMP, record, and operation compliance, and elimination of potential risks. 負責包裝現場的cGMP、紀錄、操作的合規性，以及消除潛在風險。 Periodically review and revise the GMP documents(e.g., SOP, etc.) to ensure documentation compliance. 週期性審核GMP文件(如: SOP)以確保文件與流程吻合。 Involved in the cross-function optimization project to increase the process from the quality perspective. 參與跨部門優化專案以期從品質角度提升流程。 1. Responsible for the GMP operation effectiveness on the packaging production sites. 負責包裝現場的GMP操作有效性。 2. Responsible for the site work in progress and AQL sampling following appropriate specifications. 負責現場的製程間管控(IPC)以及AQL取樣符合規範。 3. To perform the line clearance confirmation to eliminate the mix-up risks. 執行清線確認以消除混批風險。 4. To perform periodic reviews of the GMP document for the packaging, provide and proceed to the optimization proposal about the detected gaps. 執行週期性包裝部門相關GMP文件審核，針對偵測到的流程不足提案/執行優化建議。 5 To govern and enforce the cGMP processes, 5S, implemented CAPA, and quality procedures are in place and follow
- 面議（經常性薪資達4萬元或以上） 台北市信義區 5年工作經驗 1天前更新展開
1. Provide leadership and manage the work activities of direct reports in the area of application development for Commercial-off-the-Shelf applications that includes new solutions and enhancement of existing applications 2. Collaborate with business and key IT stakeholders to plan, prioritize, and schedule applications development and enhancement requests, while providing direction and guidance to the applications development staff 3. Accountable for availability and performance of applications portfolio, including ownership of incidents and release management 4. Drives stakeholder satisfaction by delivering quality applications and support with controlled and planned change management and communicate project status to various levels of management 5. Partner with leaders of other disciplines to ensure proposed solutions align with information, technology, infrastructure, business and security architectures 6. Provide oversight in standards adherence through reviews of project work including detailed technical specifications and application code 7. Proven experience in managing relationships with vendors/consultants, IT teams and internal stakeholders 8. A passion for all things tech and a drive to experiment with new technologies to see where they can benefit the business and staying hands-on technical as well as wearing that team management hat
- 面議（經常性薪資達4萬元或以上） 南投縣南投市 1年工作經驗 1天前更新展開
1. Facilitate Lot disposition process, reviewing GMP docs and managing timelines. 2. Support day-to-day Quality Assurance - Operations. 3. Perform batch disposition activities within specified timelines. 4. Ensure timely review of batch records, SOPs, investigations, and adherence to quality agreements. 5. Set meaningful goals, metrics for groups, and manage performance. 6. Ensure safe, quality, and timely work. 7. Participate in continuous improvement projects, including QA systems and shopfloor processes. 8. Manage non-conformances investigation and compliance. 9. Ensure quality production and operation in accordance with schedule. 10. Quality Assurance management, covering documentation control, batch record review, investigations, production support, training, and compliance initiatives.
- 月薪44280~44280元 台北市中正區 工作經歷不拘 3天前更新展開
1.協助執行循環農業計畫專案管考與資料彙整。 2.協助循環農業政策發展趨勢相關資料蒐集分析。 3.協助辦理會議、工作坊、整理會議紀錄與訪談資料。 4.計畫行政聯繫事務與追蹤計畫執行成果。 5.其他臨時交辦事項。 農業推廣、農業經濟、農林漁牧等農業相關系所碩士(含)以上畢業。 (依法進用保障名額，具原住民身分尤佳) (薪資待遇：碩士畢業44,280元) 工作地點:臺北市愛國東路22號7樓(產業發展中心) 經歷要求： 1.具執行政府研究計畫經驗者尤佳。 職能條件： 1.積極主動、學習力強、具團隊合作精神、良好溝通協調能力與自我管理能力，可確實掌握工作進度與業務內容。 2.具資料收集分析與彙整寫作能力。 3.熟悉辦公室文書處理應用軟體Outlook、Word、Excel、PPT等。 4.具小客車駕照，可配合出差(國內為主)。 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）
產假產檢假良好升遷制度尾牙員工在職教育訓練 - 面議（經常性薪資達4萬元或以上） 台北市信義區 工作經歷不拘 1天前更新展開
1、國際/國內永續ESG及公司治理資訊搜集與分析 2、利害關係人溝通：官網建置與更新、利害關係人需求回應 3、永續報告書編製並回覆國際永續評比 4、公益活動洽談及執行 5、公司永續目標進度追蹤 *本職缺為3~6個月短期約聘
- 面議（經常性薪資達4萬元或以上） 台北市信義區 工作經歷不拘 1天前更新展開
1. 協助對內、對外溝通資料彙整 2. 對外溝通簡報設計 3. 公司社群媒體圖像設計製作及文字編撰 4. 協助執行公司官網建置設計與更新、利害關係人需求回應 5. 熟悉 Photoshop / Illustrator 軟體佳 *本職缺為3~6個月短期約聘
- 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 1天前更新展開
1. Coordinate schedule, including meetings, appointments, and travel to ensure smooth running 2. Screen and manage mails and documents, and communicate with other departments and staff 3. Prepare presentation decks, materials and meeting minutes, and attend meetings as requested 4. Prepare and manage correspondence, and summarize documents 5. Maintain confidentiality of sensitive information 6. Handle and process documentation and other administrative tasks 7. Prepare reports, plans, and budgets for meetings
- 面議（經常性薪資達4萬元或以上） 南投縣南投市 2年工作經驗 1天前更新展開
1. Establish analytical methods of microbial and execute method validation to ensure analytical method accuracy. 2. Issue blank test report for conduct raw material/package material, semi- product/product and stability analysis, sampling and records, to ensure product quality meets PIC/S GMP requirements. 3. Review of project plans and analysis result reports, inspection/test reports, and SOPs. 4. Conduct test on water for production, Total organic Carbon of water system in laboratory systems and microbial test to ensure the quality of the water. 5. Conduct preparations of growth mediums and potency and growth tests of growth mediums to ensure microbial test run smoothly. 6. Conduct bacterial sub-culturing ,culturing, identification and counts to ensure microbial tests run smoothly. 7. Conduct environmental monitoring of production zones A,B and C(bacterial test on air conditioning system to ensure the conditions of production environment meets GMP requirements. 8. Conduct cleaning and maintenance of all instruments and equipment, calibrations/validations and sort yearly assessment reports to maintain normal usage of instruments and equipment. 9. Perform self-inspections or internal audits as required by the audit schedule.
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