轉職找工作推薦

  • YouBike-新營-維調專員(南) 面試心得
  • 企業名 YouBike微笑單車 / 捷安特 / 巨大機械
  • 工作地點 台南市新營區
  • 薪資 月薪33600~38600元
  • 工作內容 1. 自行車及租賃設備保養維修 2. 租賃場站設備保養與維護 3. 自行車調度系統規劃與管理 4. 自行車搬運調度運作管理 5. 主管交辦事項 ※上班地點可依居住地或個人意願分派： 南維調中心-台南市安南區 北維調中心-台南市鹽水區 太新維調中心-台南市仁德區
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    • YouBike微笑單車 / 捷安特 / 巨大機械-使用1111轉職專區 https://central1111.com.tw/turn/
應徵
工作適配度－%

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根據履歷表的填寫狀況，智慧分析您與工作的適配程度。

8/27

  • 法規策略計畫(資深)專員 Regulatory Affairs (Sr.) Specialist
  • 企業名 美時化學製藥股份有限公司
  • 工作地點 台北市信義區
  • 薪資 月薪33600~38600元
  • 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
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    • 美時化學製藥股份有限公司-使用1111轉職專區 https://central1111.com.tw/turn/
應徵
工作適配度－%

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根據履歷表的填寫狀況，智慧分析您與工作的適配程度。

8/27

  • 內部稽核 Internal Auditor
  • 企業名 美時化學製藥股份有限公司
  • 工作地點 台北市信義區
  • 薪資 月薪33600~38600元
  • 工作內容 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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    • 美時化學製藥股份有限公司-使用1111轉職專區 https://central1111.com.tw/turn/
應徵
工作適配度－%

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根據履歷表的填寫狀況，智慧分析您與工作的適配程度。

8/27

  • SAP(資深)專員 SAP (Sr.) Specialist
  • 企業名 美時化學製藥股份有限公司
  • 工作地點 台北市信義區
  • 薪資 月薪33600~38600元
  • 工作內容 1. Support and facilitate business user‘s requirement to seamlessly running at corporate SAP system 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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    • 美時化學製藥股份有限公司-使用1111轉職專區 https://central1111.com.tw/turn/
應徵
工作適配度－%

登入 後即可查看

根據履歷表的填寫狀況，智慧分析您與工作的適配程度。

8/27

應徵
工作適配度－%

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根據履歷表的填寫狀況，智慧分析您與工作的適配程度。

8/27

  • 法規(資深)專員 Regulatory Affairs (Sr.) Specialist
  • 企業名 美時化學製藥股份有限公司
  • 工作地點 南投縣南投市
  • 薪資 月薪33600~38600元
  • 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.
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    • 美時化學製藥股份有限公司-使用1111轉職專區 https://central1111.com.tw/turn/
應徵
工作適配度－%

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根據履歷表的填寫狀況，智慧分析您與工作的適配程度。

8/27

  • 品質系統經(副)理 Quality Systems (Assistant) Manager
  • 企業名 美時化學製藥股份有限公司
  • 工作地點 南投縣南投市
  • 薪資 月薪33600~38600元
  • 工作內容 OVERALL OBJECTIVES: -Provide leadership and oversight of designated GxP Computerized Systems (that have are relevant for Lotus Pharmaceutical) and their support teams to ensure successful delivery of key objectives, as well as compliance with applicable business and regulatory requirements. -Work with teams to implement quality systems and improvements that meet local business and regulatory requirements. -Responsibilities include administration and management of the Electronic Document Management System (EDMS), Electronic Quality Management System (EQMS), Learning Management System (LMS), as well as extended support and oversight of other GxP systems. GENERAL DUTIES: -Ensure the following key areas of GxP computerized system governance are established and maintained for applicable systems -Management: Validation planning, supplier assessment, risk management -Development 1. Validation approach & deliverables – maintain current “as is” validation state 2. Configuration and design 3. Management, development, testing, and review of software 4. Data management -Operation 1. Support services, performance monitoring, incident management, security, training, user authorizations 2. CAPA, change management, updates/patches, repair activity 3. Data integrity, periodic review, backup and restore, business continuity -Quality lead on designated Computer Systems implementations, ensuring all regulatory and compliance issues are addressed and documented -Mentor staff working on GxP computer system validation -Lead and support improvement projects to solve problems, enhance system capabilities, and expand use of GxP systems to new sites and functional areas in need. -Work with relevant teams to maintain capabilities for collecting and reporting Quality data and projects, including maintaining Quality SharePoint Portals where necessary. -Participate in internal and supplier audits as requested. -Participate in improvement initiatives and programs as requested. -Stay current with GxP and industry standards QUALIFICATIONS: -Bachelor’s degree in pharmacy or life science, or higher degree, with the right combination of extensive experience and success in the pharmaceutical industry -Education in computer science, coding or programming is a benefit -Thorough knowledge of pharmaceutical industry, quality systems, computerized system validation, GAMP 5, and relevant GxP and data integrity requirements. -Experience and skills related to the operation, administration, and overall governance of GxP computer systems and software applications. -Working knowledge of help desk software/support, databases, SaaS, and analytical reporting -Strong technical background and ability to explain complex information in simple, clear terms to non-IT personnel. Ability to assess customers IT knowledge and provide appropriate support. -Proven track record of successful GxP Computer System implementations and governance. -More than 10 years’ experience in different quality related roles within the pharmaceutical industry -Good knowledge and experience in Project Management principles and techniques. -Thorough knowledge of Quality Systems and risk-based decision making. -Experience dealing directly with regulatory agencies -Experience and skills in operating across and between different national cultures. -Good command of Mandarin and English SKILLS: -Strong leadership/team management skills -Credible and confident communicator with good presentation skills (written and verbal). -Strategic thinker with the ability to influence at all levels -Strong analytical and problem-solving ability, including identifying potential solutions, recommending and implementing methods, procedures and/or techniques for resolution. -Able to work proactively and independently.
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    • 美時化學製藥股份有限公司-使用1111轉職專區 https://central1111.com.tw/turn/
應徵
工作適配度－%

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根據履歷表的填寫狀況，智慧分析您與工作的適配程度。

8/27

  • (資深)分析研究員 (Sr.) Analytical Researcher
  • 企業名 美時化學製藥股份有限公司
  • 工作地點 南投縣南投市
  • 薪資 月薪37000~70000元
  • 工作內容 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,LC-MS 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，LC-MS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 opera
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    • 美時化學製藥股份有限公司-使用1111轉職專區 https://central1111.com.tw/turn/
應徵
工作適配度－%

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根據履歷表的填寫狀況，智慧分析您與工作的適配程度。

8/27

  • 需求計畫(資深)專員 Demand Planning (Senior) Specialist
  • 企業名 美時化學製藥股份有限公司
  • 工作地點 南投縣南投市
  • 薪資 月薪37000~70000元
  • 工作內容 1. Per Each planning cycle to organize monthly sales forecast into campaign demand plan/bulk plan for production planning team to calculate the capacity requirement, material procurement plan and form the master schedule. 2. Prepare required data, challenge, reviews to report in monthly Domestic/Export S&OP meeting; confirming market demand with CS and Marketing team in the meeting. 3. Track demand forecast and sales/B2B order progress to ensure the supply schedule meets customer requirement. 4. Track production, testing and release progress to ensure the shipment schedule is followed. 5. New product launches-Ensure that all activities are aligned and provide timely submission of net requirements and orders. 6. Trigger escalation process as necessary. Identify and address potential supply issues pro-actively. Inform sales & marketing team on the potential supply risk timely. Recording all delay root cause for each shipment. 7. As Supply planner coordinate with demand planner, who oversees domestic market product, to manage local CMO PO Placement to meet inventory requirement. SPOC, escalation to TPP representatives for domestic TW CMO. 8. Intradepartmental communication and coordination and assisting in completing work assigned by superior.
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    • 美時化學製藥股份有限公司-使用1111轉職專區 https://central1111.com.tw/turn/
應徵
工作適配度－%

登入 後即可查看

根據履歷表的填寫狀況，智慧分析您與工作的適配程度。

8/27

應徵
工作適配度－%

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根據履歷表的填寫狀況，智慧分析您與工作的適配程度。

8/27

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