• 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 2天前更新
    Job Summary: This position is based at Lotus Taipei office and involves working closely with the local RA teams to manage the registration for in-licensing products. The role is accountable for RA experiences in new submissions and life-cycle management across both Asia and Southeast Asia. English communicative skills in spoken and writing clearly, concisely, and effectively are essential. This role offers exposure to an international RA environment and facilitates the development of expertise in regulatory affairs and project management. 1. Initiate, coordinate and supervise the registration of medicinal products from the company portfolio through national procedures in the APAC region. 2. Coordinating the evaluation of possible regulatory strategies and provide support for preliminary reviews of new projects. 3. Providing support for samples preparation and dispatch, when necessary. 4. Ensuring all the additional processes relating national submissions (pre-reviews, DMF, PMF and GMP accreditation etc.) are submitted on time and those submissions/approval processes do not delay drug registration. 5. Communicating with third parties in order to expedite submissions and ensure regulatory compliance. 6. Ensuring all responses to authorities’ requests are correct, complete and timely submitted, including the responses to LoDs for the allocated projects as well as the ones related to PI for all the ongoing procedures. 7. Ensuring that accurate and complete information is timely provided to other departments/third parties and inform the relevant functions on the status and progress of the assigned projects in order to meet the set objectives, identify potential problems or delays, and possible solutions, as they occur. 8. Controlling costs and ensure proper internal evaluation and approval for each cost before it is being generated. 9. Providing support for documents and samples preparation for tenders and legal activities related to patents. 10. Coordinating the arrangements for inspections requested by the local authorities. 11. Maintaining the current knowledge of applicable legislation within the responsibility area in line with the most up-to-date provisions. 12. Ensuring that the internal regulatory database applicable trackers and SharePoint locations are kept up-to-date.
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  • 面議(經常性薪資達4萬元或以上) 台北市信義區 1年工作經驗 2天前更新
    1.藥品安全性監視計畫之執行及嚴重不良反應通報。 Execution of drug safety surveillance program and reporting of serious adverse events. 2.藥品/醫材上市後變更及展延送件 Submission of renewal and variations for drugs and medical devices 3.跨部門溝通 Work closely with project teams. 4.送件資料歸檔及維護 Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted. 5.其他主管上級交辦事項 Complete assigned tasks
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  • 月薪35000~50000元 台中市西區 1年工作經驗 2天前更新
    1.開發潛在客戶,拓展市場,以達成業績目標。 2.定期拜訪經銷客戶,維繫穩定客戶關係。 3.負責國內業務接洽及訂單處理。 4.負責產品報價及產品展示,並處理帳款回收相關事宜。 5.負責業務推展,傳達及說明公司各項業務重大訊息、活動及產品。 6.台中地區業務
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    勞保健保加班費週休二日
  • 月薪37000元 南投縣南投市 工作經歷不拘 2天前更新
    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.
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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 2天前更新
    1. Responsible for ensuring “Good Laboratory Practices” required for analytical research and development , working knowledge of good development/manufacturing practices of formulation development will be added advantage. 2.Compliance review of API, Raw materials, Packaging materials documentation. 3.Compliance review of Stability data for submission batches documentation at regular intervals. 4.Ensure Document management archival procedure followed in place and support for compliance. 5.Active participate in Internal audit on all functional area pertaining to quality system and compliance and support regulatory audits readiness. 6.Ensure compliance of issuance/document control towards internal/external stake-holders. 7.Compliance review of raw data of Regulatory submission and Audit focused documents ensure error free documentation. 8.Conduct training-based training need identification, co-ordinate internal and external training programs and maintain training records of the team members. 9.Support document review for CTA documents. 10.Review and approve of New Equipment qualifications within R&D 11.Ensure Equipment/Instrument calibration and Qualification/Requalification programs adequacy as per the schedule. 12.Ensure Document compliance review at respective stages of Product development at kick off stage, Pilot Bio, Submission batches and filing stage. 13.Regular inspections on laboratories of development labs of both analytical and formulation 14.Any other responsibilities given Head of the Department /Management
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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 2天前更新
    1. Utilizing strategic sourcing process to identify, negotiate and implement packaging materials, indirect materials, procurement initiatives to drive cost savings. 2. Align with sourcing team to provide local business requirements and market information to support effective collaborative regional strategy creation and execution 3. Partnering with RD / RA/ NPL, and other Functional groups (Executives, Quality, R&D, Regulatory Affairs, Finance, Legal, Engineering….) in discovery, contract negotiation, optimizing economic value, on-time delivery of product & services, cost management & reduction, supplier & partner risk mitigation, and scope of work development. 4. Develop and implement forward thinking procurement strategies to both optimize spending and minimize risk. 5. Creation of effective preferred supplier program and instillation of organizational discipline on onboarding new vendors. 6. Development of KPIs for strategic sourcing with cyclical delivery which drives continuous improvement. 7. Work at Nantou site at least 2-3 days per week
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  • 面議(經常性薪資達4萬元或以上) 台中市西屯區 10年工作經驗 2天前更新
    Managing the Procurement activities and all related activities regarding Indirect Materials, Packaging Materials, Capital, such as strategic sourcing, commercial negotiations, contract administration, and supplier relationship management. 1. Executes the Company‘s Procurement Strategy 2. Responsible and accountable for achieving targeted results, including cost savings 3. Utilize should-cost models for assigned categories that are benchmarked and relevant to the global marketplace 4. Provide market intelligence and price trends to relevant internal stakeholders on a disciplined schedule 5. Lead on sourcing events/RFQ process and ensure the company‘s needs for the materials/service in the category managed are supplied at the right time, in the right quantities and at the right price 6. Build and maintain strong and fair relationships with all external suppliers and all internal stakeholders 7. Develop a contract strategy for each project, including to create, negotiate, monitor and enforce contracted terms and conditions 8. Collaborate internally to drive and develop key performance measures/metrics for Strategic Suppliers and monitor supplier performance against these expectations to ensure continuous supplier improvement 9. Enlist senior management, when appropriate, to help reinforce commitment and involvement from suppliers 10. Develops and maintains a strong supply market knowledge 11. Work at Nantou Site 2-3 day per week
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  • 面議(經常性薪資達4萬元或以上) 台北市內湖區 工作經歷不拘 42天前更新
    主要工作內容為介紹及協助醫院使用本公司代理之外科產品 銷售對象為各大醫院一般外科,神經外科.骨科、心臟外科等科系 專科以上無經驗者可 。 有醫療產品銷售經驗或醫院護理工作經驗佳。
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    年節獎金員工生日禮金年終獎金三節獎金意外險
  • 面議(經常性薪資達4萬元或以上) 雲林縣斗六市 3年工作經驗 3天前更新
    1.根據公司有機肥料產品,結合植物營養所需之相關應用、管理、測試、紀錄與資料彙整。 2.對內協助植物營養專業內容與技術性文宣撰寫;對外蒐整客戶問題,提供相關諮詢服務 與建議。 3.協助試驗量級與噸級之發酵生產製程、持續製程提升方案。 4.廠區設備操作、清潔、保養維護與環境整理 5. 依照生產排程執行生產、確保品質與交期達成、完整記錄生產文件。 6. 協助銷售業務之技術輔導工作,並參與產品推廣、客戶服務相關事宜。 7.化學、生物、植病、農學、分析化學或理工農等相關科系。有品管分析經驗尤佳。能獨立操作HPLC、GC、PCR優先錄用 8.有獨立作業的能力及獨立自主組織能力,並能撰寫有系統之報告。 9.協助國內外農藥、肥料許可證新申請案、許可證照展延追蹤、使用範圍擴大延伸登記、相關變更事項等相關業務。 10.協助防檢局GHS產品之標示設計,廣告設計,產品說明會之籌備。 協助技術文件的摘要撰寫、聯絡、校正、農藥標示的品管等 11. 其他主管交辦事項. 配合及參與公司年度重要商展活動等。
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    家庭日員工結婚補助生育補助子女教育補助員工國內、外進修補助
  • 月薪35000元 雲林縣斗六市 工作經歷不拘 今天剛更新
    1. 能獨立作業完成財務會計之工作流程。 2. 審核公司內部各項費用支付憑證及帳務流程處理。 3. 編製各類財務報表及分析。 公司發展/遠景: 科技導入農業創新、量產及行銷,建立市場需求及消費導向之產業化發展環境,使農業成為高競爭力產業,運用微生物處理技術保護生態環境。藉此影響更多人學習關懷環境,尊重萬物生存規律,從淨化土壤開始,進而淨化身體及心靈,並發揮土壤最大的經濟效益,活化它並善加利用,成為全台灣最大的有機廢棄物處理廠及最大的有機肥料供應商。帶領團隊深耕台灣,放眼亞洲及全球,站穩綠色永續循環經濟產業地位,我們將能扮演著重要的關鍵角色。 成就/樂趣: 法定項目:勞保、健保、勞退、週休二日、特別休假 福利制度:獎金類 - 年終獎金、禮品、績效獎金      娛樂類 - 員工聚餐、尾牙、春酒      其 他 - 員工在職教育訓練、良好升遷制度
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    家庭日員工結婚補助生育補助子女教育補助員工國內、外進修補助
  • 面議(經常性薪資達4萬元或以上) 雲林縣斗六市 3年工作經驗 1天前更新
    1.領導指揮全廠工作人員執行工作 落實法令及契約規定,綜理各項作業之決策事宜。 2.分析與評估各項工作之成效並改進之。分析業界最新資訊,留意日後產業市場變化。 3.規劃及審核公司各項管理制度,以符合經營管理之需求。 4.維護與開發通路,促進業務發展並因應市場機制擬定及執行策略計劃。 5.核閱各項記錄資料,推動各操作之最佳化模式。 協助公司推動改革創新之策略及經營目標。 6.擬訂工作計畫,維持廠內正常作業程序與確保各設備操作運轉效果 6.定期召開經營會議並落實、督促和協調各部門的工作進展。 7.針對當前市場景氣形態調整行銷策略與需求分析。 8.複核及品管各種工作報告與記錄。 9. 策劃敦親睦鄰活動及對外相關業務之推動。 10. 指揮執行緊急應變措施,統籌運用調度人員及機具車輛 11.其他公司交辦之事項
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    家庭日員工結婚補助生育補助子女教育補助員工國內、外進修補助
  • 月薪40000元 桃園市中壢區 工作經歷不拘 1天前更新
    職位描述: 我們是一家專注於生技創新的公司,現正尋找一位充滿熱情的總經理特助,協助主管推動公司的發展與策略執行。此職位將直接參與公司的日常運營,並在多個專案中提供支持。 主要職責: 協助總經理制定和執行公司策略,參與高層決策過程。 負責整理和分析市場資料,提供決策支持。 協調內部各部門的溝通與合作,確保專案的順利進行。 準備會議資料,記錄會議紀錄並跟進會議決議事項。 管理日常行政事務,包括行程安排、文件處理等。 任職要求: 大學以上學歷,生技、管理或相關領域背景者佳。 具備良好的溝通能力和團隊合作精神。 具備分析能力,能夠處理複雜的數據和資訊。 熟悉Microsoft Office(Word、Excel、PowerPoint)及其他辦公軟體。 具備良好的英文能力,能夠撰寫商業信函及報告。 我們提供: 友善的工作環境與團隊氛圍。 發展潛力與晉升機會。 參與生技創新項目的機會,提升專業技能。
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    產假全勤獎金年節獎金員工生日禮金年終獎金
  • 面議(經常性薪資達4萬元或以上) 高雄市苓雅區 2年工作經驗 3天前更新
    1.具ISO、 GLP、QMS等相關品保經驗 2.醫療器材QMS設計開發品質管理系統建置及維護 3.研發部品保制度規劃與建立 4.相關文件管理、維護及修訂 5.培訓指導相關人員,提升品質管理意識 6.其餘主管交辦事項
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    全勤獎金勞保健保加班費
  • 月薪35000元 高雄市苓雅區 2年工作經驗 3天前更新
    1. 辦理銀行相關作業。 2. 執行一般現金收付作業。 3. 零用金管理作業。 4. 處理客戶/廠商貨款等應收/付款項、發票、單據及帳務處理帳務。 5. 處理其他一般會計帳務。 6. 處理其他主管交辦事項。 本職位為公司財務部門的重要成員,可以提供穩定的工作機會以及良好的職涯發展前景。 歡迎有興趣的應徵者投遞履歷表,我們期待著與您共同發展。
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    全勤獎金勞保健保加班費
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