交大專區

1.生產設備維修及保養 2.簡易電路維修 3.專案工程協助、執行 4.配合機台搶修 5.主管交辦事項

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.

能獨立操作CNC車床機台

1. 生產設備拆修作業與設備定期保養 2. 電路控制基本維修與機電故障異常查修排除 3. 主管交辦事務處理

1. 有表面活性劑研發或印染廠相關工作經驗者、或印染實驗室經驗者，尤佳 2. 印染助劑開發及應用實驗 3. 紡織漿料開發及應用實驗 4. 產品原料搜尋特性分析 5. 產品效能提升改善及異常處理 6. 產品物質安全資料相關等製作 7. 實驗報告製作、資料整理、配方建檔

電機設備裝配、保養、維修、組裝電氣配盤體、現場施工、監造等

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.電子產品之半成品及成品測試作業。 2. 需配合加班。 3. 主管交辦事項。

1. 部品驗收、備料、組裝前置作業。 2. 工具機組裝。 3. 機台操作、維護與精度確認。 4. 能配合主管工作調配，主動積極發現及改善問題。 5. 工科相關科系畢業者或具基本的機械組裝經驗佳。

1.軟體程式開發案及後續更新維護等工作。 2.線上產品功能開發、測試維護。 3.跨部門需求溝通與確認。

1.生產康普茶及產品品管 2.協助生產堅果 3.其他主管交辦事項

1.依據需求規劃與建置 RF 系統，參與從概念設計到產品量產的完整開發流程。 2.測試驗證射頻電路效能，使用網路分析儀、頻譜分析儀等儀器進行RF電路測試與優化。 3.RF線路設計、阻抗匹配、PCB佈局與除錯，確保最佳射頻性能。 4.整合、測試、優化 RFIC 模組，負責無線通信、毫米波、射頻前端電路設計。 5.作為客戶技術窗口，協助技術問題溝通，參與專案會議並提供技術報告。