交大專區

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

1.懂基本水電 2.安裝、維修及配置照明設備。開孔、維護並修理包括電線、變壓器、燈具...等相關設備。 3.使用配線電路圖和測試儀器，鑑定有問題之區域性設備燈具、變壓器。 4.電線、燈帶、鋁條...等材料裁切，燈帶焊接 5.主管交辦事項處理 6.需配合加班 7.肯學習/配合度高/吃苦耐勞 /邏輯能力/理解力高 /靈活度高 8.有安裝燈具經驗者優先錄取及具汽車駕照者優先錄取~ 9.無經驗亦可 伙食費,加班費另計 享勞,健,團保 **無誠勿試**

1.水質淨化場處理系統操作及維護 2.每日巡場及抄表記錄 3.場區環境維護整理 4.例行操作報表填寫 5.其他主管交辦之任務

1. 綜理水質淨化場操作維護相關業務 2. 業主/主管臨時交辦工作

1.製作、安裝、與維修相關板金產品 2.金屬板片之剪切、成形 3.依據施工圖，辨別材料特性，選擇適合的焊接方式及填料、焊條，進行金屬加工工序 4.檢測焊道，以目視檢查焊道是否有穿焊、焊蝕、滲透不足、裂紋等缺陷 鑽孔.攻牙.組裝.砂輪機...... 5.獨立升降桌.焊接設備 焊接電控箱,水電箱,或一般板金焊接 氬焊白鐵.co2黑鐵 依能力不定期加薪!! 夜間部同學,歡迎你!

1.安裝、維修建築物或室外之給水與排水系統。 2.安裝、維修建築物之電線管路與用電設備。 3.安裝、維修及配置照明設備。 4.安裝、維修家電或廚衛設備。 5.消防設備維修更新。

屬鐵件工程 1.廠內加工作業、現場安裝 2.營建業不銹鋼金屬工程 3.不銹鋼扶手、欄杆、鐵件工程，鋼構工程 加工安裝

屬鐵件工程 1.廠內加工作業、現場安裝 2.營建業不銹鋼金屬工程 3.不銹鋼扶手、欄杆、鐵件工程，鋼構工程 加工安裝

線路架設，系統整合，配管配線