交大專區

1. 協助工程師專案進行、修改圖面與出圖。 2.2D、3D圖面整理及繪製、研發文件發行與歸檔。 3.品號編訂、ERP BOM表建立與修改之電腦資料維護管理。 4.工程變更作業執行與管理。 5.協助主管處理交辦事項。

1 .製作工程合約書.計劃書 2.維護、更新、管理各類文件檔案（如：合約、會議記錄、書目資料）。 3.完成工作時程表，管理施工進度，並負責會議協調與安排。 4.工程費用報價、控管及報表製作。 5.收發公文並分類歸檔。

【工作職責】 1.參與微軟商務產品 Power Platform相關專案開發 2.系統報表、表單、自動化流程開發與修改 3.Microsoft Azure AI及Microsoft Copilot Studio相關開發 4.完成主管交辦事項 【其他條件】 1.熟悉 Power Platform, Microsoft Dynamics 365 為佳 2. 熟悉 Microsoft Azure AI, Microsoft Copilot Studio 應用為佳 3.積極主動、喜學習新事物、具抗壓性 4. 具備微軟相關證照尤佳

1.判斷金屬材料性質和工作性質，以選擇適當之刀具 2.將待加工之工件固定於機器夾頭，或其他夾具 3.安裝所選用之刀具於刀架上，固定於機器心軸之適當位置，並確實夾緊，以防工作中鬆動，降低精確度 4.開動機器，操縱手輪進刀或進料，依一定規格精確的切削 5.依檢查結果，調整進刀尺寸及切削速度，以完成一定規格之各類產品 6.卸下成品，清理機器及上油

1.將施工圖樣轉換成 CNC程式編輯(熟MasterCam尤佳) 2.CNC車床機台操作，包含準備刀具、 3.CNC車床機台的維護包含故障排除、保養等 4.負責產品量測及自檢，協助製程品質 5.依照工作圖或實樣準備材料、工具、刀具、量具

1.監督水電工程現場施工 2.水電消防配管配線、高低壓電氣設備安裝 3.按照藍圖進行高低壓配電線路施工、電路維修及電器設備安裝 4.一般建築物的供水與消防給水管路的簡單基本設計、施工與維護，含污水、排水系統 5.照明燈具、開關插座安裝、火警消防設備安裝、UPS不斷電設備安裝 6.水電費核銷 7.主管交辦事項

1.基礎6S巡檢。 2.半導體生產設備裝配、保養、校正。 3.協助檢測各類電子產品及設備。 4.更換、修繕零件及簡易故障排除。 5.主管交辦事項。

1.負責射出機生産線機器、設備之操作，維持機台正常運作。 2.負責試模及更換模具。 3.機台換料送料，調整及故障排除，符合生產及程序標準。 4.填寫生產報表，以檢視與生產目標的距離。 5.完成主管交辦有關生產產品、程序事宜。 6.享勞健保。 7.能配合加班尤佳。 **請先投遞履歷表或電洽面試時間**

1.新機台到客戶廠房後安裝及試運轉。 2. 客戶廠內機台維修故障排除及零件更換。

公共路燈工程、照明燈具設備裝設、水電機電裝設維護、新建廠房水電

1.從事網際網路系統軟硬體與程式語言的開發、測試及安裝 2.網站上線後的維護與功能更新 3.後端網頁系統開發 4.資料庫程式開發 5.平台系統架構規劃及設計 6.從事相關系統程式開發、管理與維護，及客戶服務與支援 7.企業內部系統規劃與開發MIS系統的功能，以符合企業需求 8.維護公司網路和資料，並進行備份工作，及防毒 9.配合資訊作業需要，至各單位處理連線相關作業及問題排除 10.擔任各項資訊系統整合與維護、及測試工作 11.負責Fire Wall、IDS及防毒軟體等資安系統管理防止公司機密外洩以及員工不當使用電腦

1.熟Auto Cad或Solid Works. 2.依圖面進行抄圖,或展開.

高低壓電氣設備檢測及維護保養。 認真肯學習,配合度及積極度高,無經驗可。歡迎優秀的人才加入我們的工作行列。

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。

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

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.

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.

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.

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

1.日本精密CNC車床機器操作，進行金屬或塑膠原料的切削與製作工作 2.協助管理生產流程、控制工件尺寸及品質、加工現場安全管理 3.負責產品生產與量測，協助改善製程品質與追蹤 4.車床操作機器設備之保養與維護 5.製作日報表 (領取原料之數量、加工刀具應用及生產時間和生產數量) 6.判斷金屬材料特性和加工性質，以選擇適當之刀具 7.將需要加工之工件固定於機器夾頭，或其他治工具 8.安裝所選用之刀具於刀架上，固定於機器心軸之適當位置，並確實夾緊，以防工作中鬆動，提高品質準確度 9.啟動機器，操作進刀及進料，依生產圖面之規範精確的切削生產 10.產出成品，調整機器 11.生產機器操作及平常的機械保養與清潔