進入內容區塊

國立陽明交通大學學生事務處

::: 網站導覽 回首頁 EN FB 本處單位 陽明交大
  • 字型大小-小
  • 字型大小-中
  • 字型大小-大
搜尋

生醫徵才

  • 更新日期：114-04-17
  • 發布單位：職涯發展組
【2025生醫產業趨勢x企業說明會】4/23(三) 美時化學製藥股份有限公司-職缺搶先看
【2025生醫產業趨勢x企業說明會】4/23(三) 美時化學製藥股份有限公司-職缺搶先看
公司名稱：美時化學製藥股份有限公司
企業類別：製藥企業
參加場次：4/23(三)12:00-13:30
講座主題：製藥產業的發展趨勢及職涯之路
收取履歷：現場及提前接收履歷
辦理面試：後續安排
履歷寄送至：職發組劉沛毓輔導員py.ym@nycu.edu.tw，履歷請註記【應徵公司】及【應徵職務名稱】
講座報名請點此

【美時化學製藥股份有限公司職缺資訊】
  • 職務名稱1、企業品質合規(資深) 專員Corporate Quality & Compliance (Sr.) Specialist      
    • 工作內容
      • 1. Maintain and update the Corporate Quality Manual and Standards to comply with international regulatory guidance, including US FDA, EMA, ANVSIA, ICH, and PIC/S.
      • 2. Conduct regulatory surveillance, monitor updates and trends, and implement necessary revisions to quality standards.
      • 3. Ensure compliance with Corporate Quality Standards across all Lotus sites through collaboration, audits, and follow-up on corrective actions.
      • 4. Oversee supplier and third-party qualifications, including GMP audit scheduling, report review, and managing responses to observations.
      • 5. Support regulatory inspections and customer audits at Lotus sites, including CAPA plan development and standard revisions based on findings.
      • 6. Manage GMP compliance, non-conformance investigations, and adherence to quality agreements and standards.
      • 7. Collaborate with cross-functional departments to meet GxP requirements and drive continuous improvement projects.
      • 8. Handle document control, quality investigations, and enforce compliance with established standards.
      • 9. Manage team budgets effectively and ensure resource allocation aligns with operational goals. 
    • 資格條件
      • 工作經歷：3年以上
      • 學歷要求：大學、碩士
      • 科系要求：化學相關、藥學相關、生物學相關
      • 語文條件：英文 -- 聽 /中等、說 /中等、讀 /精通、寫 /精通
      • 擅長工具：Excel、Outlook、PowerPoint、Word
      • 其他條件：
        1. Familiar with PIC/S
        2. Experience with US/EU/TFDA inspections
        3. Familiar with electronic management system
        4. Familiar with CFR Title 21
        5. Familiar with EudraLex Vol. 4
        6. Good interpersonal/communication skills, ability to interact effectively in a team environment within the functional team and with all cross functions and attention to details.
    • 職缺需求人數：現有職缺 1名
    • 工作地點：營運中心-南投市成功一路30號
    • 薪資待遇：面議
       
  • 職務名稱2.製程品質保證(資深)專員 OQ (Sr.)Specialist      
    • 工作內容
      • 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.    
    • 資格條件
      • 工作經歷：1年以上
      • 學歷要求：大學、碩士
      • 科系要求：化學工程相關、自然科學學科類、醫藥衛生學科類
      • 語文條件：英文 -- 聽 /中等、說 /中等、讀 /中等、寫 /中等
      • 其他條件：
        Possessing the following qualifications is considered advantageous:
        1. Familiar PIC/S GMP
        2. Experience with US/EU/TFDA inspections
        ★輪班制，做二休二平均工作日15天
        日班：08:00 - 20:00
        夜班：20:00 - 08:00     
    • 職缺需求人數：現有職缺 3名
    • 工作地點：營運中心-南投市成功一路30號
    • 薪資待遇：面議
  • 職務名稱3、化學分析專員 Lab Specialist    
    • 工作內容
      • 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   
    • 資格條件
      • 工作經歷：1年以上
      • 學歷要求：大學、碩士
      • 科系要求：食品科學相關、化學相關、藥學相關
      • 語文條件：英文 -- 聽 /中等、說 /中等、讀 /中等、寫 /中等
      • 擅長工具：Excel、Outlook、PowerPoint、Word
      • 工作技能：化學檢測儀器操作、實驗室設備操作、化學分析能力
      • 其他條件：
        1.化學系, 應用化學系,食品營養系,醫藥化學系畢業者佳
        2.具藥廠相關經驗者佳          
    • 職缺需求人數：現有職缺 5名
    • 工作地點：營運中心-南投市成功一路30號
    • 薪資待遇：面議
       
  • 職務名稱4、品保專員 QA Specialist, AP       
    • 工作內容
      • 1. Facilitate the Lotus disposition process including: -Review of GMP Manufacturing Documents including Batch Records, Investigations, Deviations/CAPA, Analytical Testing Documents, and Certificates of Analysis. -Managing timelines and resources to ensure the disposition of material in accordance with Lotus' SOPs and within agreed timelines.
      • 2. Support and ensures the successful day-to-day operations for the company.
      • 3. Perform batch disposition activities in accordance with Lotus' SOPs and within agreed timelines.
      • 4. Ensure the timely review of batch records, SOPs, investigations, corrective actions, change controls, technical documents, and adherence to Quality Agreements.
      • 5. Ensuring that all work is performed safely, with quality, and in a timely, compliant manner.
      • 6. Participating in continuous improvement projects throughout the group and the facility/operational portions of the organization. This includes all QA systems and pocesses as well as those on the shopfloor through the QA on the Floor function     
    • 資格條件
      • 工作經歷：2年以上
      • 學歷要求：大學、碩士
      • 科系要求：食品科學相關、藥學相關、化學相關
      • 語文條件：英文 -- 聽 /中等、說 /中等、讀 /中等、寫 /中等    
      • 職缺需求人數：現有職缺 1名
      • 工作地點：營運中心-南投市成功一路30號
      • 薪資待遇：面議
         
  • 職務名稱5、法規專員 Regulatory Affairs Specialist    
    • 工作內容
      • 1. Review and provide the technical recommendations for CMC documentation and Common Technical Document(CTD) dossier from a regulatory perspective.
      • 2. Interpretation and Handling the regulatory technical query’s responses that were asked by Client and Authority during the due diligence or submission deficiency phase and provide the action plan or solution and scientific justification.
      • 3. Responsible for evaluating the registration feasibility and mapping the global registration strategy for assigned new R&D products.
      • 4. Cooperate and teamwork with R&D, technical, and RA PM on new R&D project technical challenges and complete the dossier till product approval.
      • 5. Responsible for regulatory registration for export products and make sure all the documents are meet the authority's requirements.
      • 6. Responsible for deficiency response preparation to ensure our response meets the authority’s requirements.
      • 7. Accurately follow the update of the registration regulation, and provide the regulation update to the team and training. 
    • 資格條件
      • 工作經歷：不拘
      • 學歷要求：大學、碩士
      • 科系要求：生物學相關、藥學相關、醫學技術及檢驗相關
      • 語文條件：英文 -- 聽 /中等、說 /中等、讀 /精通、寫 /精通
    • 職缺需求人數：現有職缺 1名
    • 工作地點：營運中心-南投市成功一路30號
    • 薪資待遇：面議
       
  • 職務名稱6、法規策略計畫專員 Regulatory Affairs  Specialist
    • 工作內容
      • 1. Evaluation of submission feasibility for in-licensed products (major) and domestically manufactured products in the APAC region (KR, TW, HK, SG, MY, TH, VN, PH, and ID)
      • 2. Coordination of the due diligence and production of the gap list
      • 3. Evaluation and plan of the design, the budget, and the timeline for the bioequivalence study, the bridging study, and the clinical study in KR and TW
      • 4. Communication with the APAC regulatory teams and partner companies to resolve the submission gap in the target markets
      • 5. Design and consolidation of the regulatory strategy of the key milestone, the submission pathway, the submission timeline, and the launch timeline in the target markets
      • 6. To review the License and Service Agreement
      • 7. To support new submissions in Taiwan
      • 8. To update of the APAC regulations
      • 9. To prepare the consultation materials
      • 10.To provide the justification materials on the non-clinical and clinical studies for the deficiency letter
      • 11. To compile the ACTD format from the CTD format
      • 12. To monitor submission progress on all company's projects
      • 13. To provide improvement plans
      • 14. The other tasks
      • 1. 協調法規相關部門與供應商評價授權產品
      • 2. 評估產品於亞太地區註冊之可行性，準備註冊所需相關技術文件與試驗
      • 3. 在產品開發及送件準備期間提供法規要求的指引，協助其符合國際法規
      • 4. 即時提供註冊用產品主檔案
      • 5. 協助提供法規更新計畫
      • 6. 即時支援產品維護用技術文件
      • 7. 協助擬定合理且經濟可行之註冊計畫
      • 8. 協助執行註冊計畫
    • 資格條件
      • 工作經歷：2年以上
      • 學歷要求：大學以上
      • 科系要求：生物學相關、藥學相關、醫學技術及檢驗相關
      • 語文條件：英文 -- 聽 /精通、說 /精通、讀 /精通、寫 /精通
      • 工作技能：簡報軟體操作
      • 其他條件：
        1. Having experience in submission in the US or EMA is a plus.
        2. Having experience in submission in TW is a plus.
        3. Having experience in submission in KR or the APAC region is a plus.
        4. With CRO background is a plus.
        5. Experience in laboratory, clinical and regulatory related work is preferred.
    • 職缺需求人數：現有職缺 1名
    • 工作地點：臺北市信義區松仁路277號17樓
    • 薪資待遇：面議

       
  • 職務名稱7、採購專員 Procurement Specialist    
    • 工作內容
      • 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    
    • 資格條件
      • 工作經歷：6年以上
      • 學歷要求：大學以上
      • 科系要求：商業及管理學科類、其他商業及管理相關、一般商業學類
      • 語文條件：英文 -- 聽 /中等、說 /中等、讀 /中等、寫 /中等
      • 擅長工具：SAP
      • 工作技能：供應商尋找及評選執行、採購談判與議價技巧、商品採購作業
    • 職缺需求人數：現有職缺 2名
    • 工作地點：台中市西屯區市政路402號
    • 薪資待遇：面議
       
  • 職務名稱8、採購數據分析師 Procurement Data Analyst  
    • 工作內容
      • Responsible for procurement data related to cost analysis, system SME (SAP S4 HANA).
      • Support Procurement Team for spending analysis, set up procurement strategy, and prepare all reports (such as cost saving report, tracking of KPI, Process flow) to allow procurement functions for strategic and systematic operation.
      • Responsibilities include but not limited to: -Generate data for historical systems and cross functions (Procurement, Finance, SAP, HANA, CAR) Power BI Report development.
         -Build Analysis Services reporting models.
         -S&OP Support: Carry out purchasing delivery tracking systematically for procurement team to ensure accurate delivery and avoid lack of material.
        -Improve Cost analysis report and maintain process through data analytics (templates, configurator)
        -Develop visual reports, KPI scorecards, and dashboards using Power BI desktop. -Responsible for designing methodology and project documentaries.
        -Power user / SME of SAP, BPM of Lotus all ERPs system
        -Prepare reports, plans, and budgets for meetings
        -Handle and process documentation and other administrative tasks
        -Work at Nantou site at least 2-3 days per week      
    • 資格條件
      • 工作經歷：1年以上
      • 學歷要求：專科、大學、碩士
      • 科系要求：不拘
      • 語文條件：英文 -- 聽 /精通、說 /精通、讀 /精通、寫 /精通
      • 擅長工具：Excel、Power BI、SAP
      • 工作技能：不拘
      • 其他條件：能於南投廠區上班者優先考慮
    • 職缺需求人數：現有職缺 1名
    • 工作地點：營運中心-南投市成功一路30號
    • 薪資待遇：面議
       
  • 職務名稱9、程式設計人才 Corporate System Integration Professional   
    • 工作內容
      • 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       
    • 資格條件
      • 工作經歷：5年以上
      • 學歷要求：大學、碩士
      • 科系要求：資訊管理相關、資訊工程相關、電機電子工程相關
      • 語文條件：英文 -- 聽 /中等、說 /中等、讀 /中等、寫 /中等
      • 擅長工具：HTTP、VueJS、CSS、JavaScript、HTML、MS SQL、C#、ASP.NET
      • 工作技能：系統架構規劃與維護、系統維護操作、資料庫軟體應用、資料庫程式設計、模組化系統設計、網路程式設計、軟體程式設計、軟體工程系統開發、系統整合分析
      • 其他條件
        ■ Familiarity with Microsoft platform development and Agile methodologies
        ■ Experience in project management and IT service management (ERP, CRM)
        ■ Strong analytical and problem-solving skills
        ■ Excellent technical abilities, including experience with database management and project management software
        ■ Knowledge of enterprise application integration software (net core 8, C#, Vue.js, SQL Server) ■ Understanding of software development and web technologies
        ■ BS/BA in Computer Science, Engineering or a related field
    • 職缺需求人數：現有職缺 1名
    • 工作地點：台北市信義區松仁路277號17樓
    • 薪資待遇：面議
       
  • 職務名稱10、儲備幹部 Management Trainee      
    • 工作內容
      • 1.協助主管規劃廠房、設備、生產、Artwork、品質制度等運作落實，以提昇部門績效。
      • 2.協助各類專案之規劃與執行。
      • 3.完善人才培訓體系及晉升發展管道。
      • 4.100％藥廠CGMP訓練。
    • 資格條件
      • 工作經歷：不拘
      • 學歷要求：碩士以上
      • 科系要求：工業技藝及機械學科類、工程學科類、醫藥衛生學科類
      • 語文條件：英文 -- 聽 /精通、說 /精通、讀 /精通、寫 /精通
      • 擅長工具：Excel、Outlook、Word
      • 工作技能：不拘
      • 其他條件：
        1. 工作態度正向、積極主動學習、樂於接受工作挑戰之人格特質
        2. 具英文溝通能力 (TOEIC>750)
        3. 兼具工程/機械/機電/藥學/science/資訊等背景，並有志於製造業者發展者。
        ＊本職務將於製造/工務/技術服務/供應鍊/品質等部門間進行工作輪調，以培植為公司未來幹部職。
    • 職缺需求人數：現有職缺 2名
    • 工作地點：營運中心-南投市成功一路30號
    • 薪資待遇：面議
       
  • 職務名稱11、公司治理專員 Corporate Governance Specialist 
    • 工作內容
      • 1.負責協助股東會、董事會、功能委員會等各項機構的運作，並協調議程安排。
      • 2.協助編製公開說明書、股東會年報以及議事手冊，確保文件內容準確完整。
      • 3.負責協助公開資訊觀測站各項公告的申報作業，包括中、英文版本的處理。
      • 4.參與公司治理評鑑的統籌與執行工作，並參與ESG專案相關作業。
      • 5.負責內部人持股異動的管理工作，確保流程順暢有效。
      • 6.處理各項變更登記申請，確保文件及程序的正確無誤。
      • 7.負責股務、公司治理相關法令的遵循與檢視，並根據上市/上櫃相關規定修訂相關作業辦法。
      • 8.處理其他股務相關作業及財務專案管理事項，確保工作順利進行。 
    • 資格條件
      • 工作經歷：1年以上
      • 學歷要求：大學、碩士
      • 科系要求：不拘
      • 語文條件：英文 -- 聽 /精通、說 /精通、讀 /精通、寫 /精通
      • 職缺需求人數：現有職缺 1名
      • 工作地點：台北市信義區松仁路277號17樓     
      • 薪資待遇：面議
         
  • 職務名稱12、業務代表    
    • 工作內容
      • 1. 具備診所通路相關業務經驗
      • 2. 市場資訊收集分析、反對意見處理
      • 3. 新開戶開發
      • 4. 客戶分級及區域管理
      • 5. 舉辦Seminar , RTD
      • 6. 推廣及開發OTC指示用藥及處方藥物      
    • 資格條件
      • 工作經歷：2年以上
      • 學歷要求：大學、碩士
      • 科系要求：生物學相關、醫藥衛生學科類
      • 語文條件：英文 -- 聽 /中等、說 /中等、讀 /中等、寫 /中等
      • 擅長工具：Excel、Outlook、PowerPoint、Word
      • 工作技能：具備駕照-普通小型車
      • 其他條件：
        1. 文書作業能力：PowerPoint(圖表呈現) 、Excel (樞紐分析)、Word(專案書寫)
        2. 具備獨立舉辦Seminar , RTD經驗
        3. 具主動積極、團隊合作、樂觀進取、勇於挑戰等特質
    • 職缺需求人數：現有職缺 6名
    • 工作地點：北中南依區域
    • 薪資待遇：面議
       
相關圖片：
回上一頁
gotop