「製造訓練人才 Manufacturing Trainer」的相似工作

Summary • The role is mainly responsible for inputting and maintaining material master data in SAP and the corporate SKU system, ensuring data accuracy and compliance with internal policies, which is a key supporting position to daily operation. In addition, this position assists with costing-related tasks and provide ad hoc support on needed basis Responsibilities • Input material master data into SAP and the corporate SKU system in a timely and accurate manner, ensuring requests comply with SAP setup standards and company policies; proactively follow up with stakeholders for any missing documentation before processing • Support the maintenance and periodic review of material data to ensure accuracy and consistency • Assist in identifying and cleaning up outdated or inactive material records • Help with SAP setup and maintenance tasks for material data under the guidance of senior team members • Maintain documentation related to material master data processes and standards • Support costing-related activities and contribute to ad hoc tasks or projects as assigned by the supervisor

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.

1.依據需求計畫部門提供的銷售預測，排定生產計劃，供製造部排定排程。 2.依據需求計畫部門提供銷售預測排定生產年度計劃，依ERP建議原物料需求建立請購計畫。 3.依據生產計畫建立工單。 4.依據採購計畫建立請購單/依據研發原物料需求建立請購單 5.依據製造排程協調原物料狀況並掌握進度。 6.固定召開生產排程會議 7.製作週報及月報表供主管參考 8.跨部門工作之溝通與協調，協助與配合完成上級交辦之工作

1. Manage 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. Provides leadership to assigned staff by performing the following: ◆ Leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals. ◆ Building effective teams that apply their diverse skills and perspectives to achieve common goals. ◆ Driving engagement and creating a climate where staff is motivated to do their best. 3. Oversees, manages, and ensures the successful day-to-day operations of Quality Assurance-Operation departments for the company. 4. Ensure the QA successfully performs batch disposition activities to meet specified timelines. 5. Ensure the timely review of batch records, SOPs, investigations, corrective actions, change controls, technical documents, and adherence to Quality Agreements. 6. Establish meaningful goals and metrics for groups in conjunction with the Site Head of Quality, and manage the performance to those goals. 7. Interfacing with customers to ensure clear and open communication is maintained when intermediate levels of escalation are required by the QA staff. 8. Communicating priorities and distributing work assignments to direct reports. Ensuring that all work performed by Staff is performed safely, with quality, and in a timely, compliant manner. 9. Leading and ensuring the group is leading and participating in continuous improvement projects throughout the group and the facility/operational portions of the organization. This includes all QA systems and processes as well as those on the shopfloor through the A on the Floor function. 10. Leading, managing, and/or participating in the investigation of non-conformances and follow-up corrective/preventative actions in compliance with quality procedures, policies, and regulations. Ensuring the group is doing the same as required. 11. Providing feedback and coaching in technical skill development, job performance, and career growth, and taking necessary disciplinary actions if necessary. Advocating for employees when required. 12. Ensuring the quality and compliant production and disposition of batches and the quality and compliant operation of all systems throughout the facility in accordance with schedule requirements. 13. GMP Supplier Oversight: ◆ Oversight of the GMP Vendor Audit Schedule. Ensuring Vendor and Auditor availability (internal/external/consultant) and confirming audit dates with both Auditors and Vendors. ◆ Review supplier audit reports, ensuring they meet Lotus QA standards and are compliant with Lotus SOPs. ◆ Submitting Observation reports to vendors, communicating response timelines, and tracking them to ensure timely responses. ◆ Review vendor audit responses and manage the review/editing cycle until responses are acceptable. ◆ Requesting documented evidence of closure when necessary and filing electronically and in hard copy. ◆ Updating CAPA trackers. 14. Quality Assurance Management: ◆ Documentation control (master batch record, specification & method). ◆ Batch record review and product disposition. ◆ Investigations, complaints, deviations, CAPAs, APRs. ◆ Production support. ◆ APRs, GMP training, and SOP review. ◆ Validation/qualification documentation review & approval. ◆ QA Operations – inspection, sampling, and review of incoming materials, perform AQL inspections, support, and drive compliance throughout the site. ◆ Departmental budget development and compliance. ◆ Regulatory and customer inspections management. ◆ Quality management review – quality board and related KPIs.

1. Provide annual demand plan according to annual sales forecast and new product introduction project progress. 依據年度銷售預測與新產品上市專案，提供年度需求計畫 2. Organize monthly sales forecast and new launch product requirement into demand plan, upload into ERP and plan the master schedule (delivery plan). 依據每月銷售預測與研發需求，整理成需求計畫並匯入ERP，以排定主排程計畫 3. Maintain reasonable inventory level and set up appropriate buffer stock to balance the supply chain delivery and inventory goals. 建立合理的庫存水準，並維持適當的安全庫存 4. Track monthly potential out of stock items, prevent stock-out risks in market, and make sure customer service level and on-time delivery meet targets. 追蹤每月可能缺貨項目，並確保市場無缺貨危機，以達成高客戶服務及準時交貨水準 5. Host and hold monthly pre-S&OP and S&OP meeting with sales and Marketing, Business Development and NPI department. 主持每月Pre-S&OP及S&OP會議，並與行銷、事業開發、新產品上市部門確認市場需求計畫 6. Track domestic demand forecast and sales/ B2B order progress to ensure the supply schedule meet customer requirement. 追蹤內銷市場預測需求及實際銷售狀況/ B2B訂單進度，確保供給計劃符合客戶要求 7. Continuously look for opportunities to improve the demand planning process, dissecting forecast errors and rectifying as needed to meet established forecasting accuracy goals. 持續改善需求計畫流程，並改進銷售預測偏差，以維持高銷售預測準確性 8. Coordinate local master data in ERP and ensure data integrity. 維護ERP主檔案，並確保資料完整性 9. Track new product launch status and ensure launch timeline meet target. 追蹤新產品上市進度，以符合預計上市時程 10. Issue purchasing requisition and maintain delivery status for domestic and global toll, merchandise, subcontracted product to ensure on time delivery 採購並追蹤委製及外購產品的交貨進度，確保達成準時交貨時程 11. Intradepartmental communication and coordination and assisting in completing work assigned by superior. 跨部門工作之溝通與協調，協助與配合完成上級交辦之工作。

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

●製程設備異常克服及改善 ●製程能力監控與提升 ●製程整合SOP撰寫 ●良率整合與分析及改善 ●專案改善規劃、執行 ●生產製程相關教育訓練計畫 ●編寫apqp\ ppap\ Fmea\管制計畫 ●關鍵材料藥液管理 ●新產品 評估送樣 ●產品製程設計及參數設定

1).日籍主管各項事務處理(住宿租賃、接送安排、居留證、訪客入境、生活突發狀況) 2).公司執照變更、股東會資料整理 3).公司各項保險業務(團保、汽機車保險、旅平險、高爾夫球證移轉與保險) 4).各項聚餐安排與聯絡、公務車調度、車輛接送安排。 5).公部門費用統計(水電瓦斯、太陽能、汙水費、電信費....等) 6).祭祀事宜(初二、初十六、頭牙、尾牙、中元節...等)、員工訃聞親屬連絡事宜。 7).品管圈(QCC)小組團隊活動、安全改善提案活動 須具備英文或日語能力(英文多益600以上、日語N2以上)，以日語為優先。 ___________________________________________________________ ●不定額生產獎金 ●福利項目-交通補助

1. 執行新進人員培訓課程，確保教學過程順利並落實培訓成效。 2. 擔任課程助教： • 鞋業基礎課程：學習並傳授鞋類基礎知識，協助學員達成學習目標。 • 語言課程：聯繫印尼語與越南語講師並協助課程推展。 3. 協助教材優化，推動與追蹤跨廠區協作專案。 4. 參與儲備講師培訓，未來負責專業授課與學習輔導。

1. 預測銷售量並擬定生產計畫。 2. 根據交期需求開立生產工單，掌握生產進度，需與業務部門、生產部門密切溝通協調，以提升交期達成率，讓生產排程更加順暢。 3. 生產進度追蹤控制。 4. 生產原物、料、客供料確認及跟催

一、客戶品質服務管理 二、品質保證(客訴案件原因分析及處理) 三、製程品質管制(品質改善活動推行及對策成效確認)

1.原料秤取 2.培養基/配製緩衝液配製 3.廠區環境消毒維護 4.製程器具清潔/包裝滅菌 5.台中/竹北GMP文件撰寫與改版 6.其他主管交辦事項

•Support the project and validation manager in preparing Project Execution Plan and update site Validation Master Plan. •Prepare and implement qualification protocols (IQ, OQ, PQ) used in the production of pharmaceutical products. Where possible, as assigned by the project manager to manage projects related to movement and modification of the manufacturing equipment. •Implement qualification activities, validation protocols, and calibrations in accordance with the needs of the production schedules. •Conduct periodic review of URS/FRS/DDS or DQ to meet the latest regulatory requirements or guidelines from ICH or FDA CFR’s. •Assist in the development and revision of Validation SOPs. •Assist in troubleshooting of equipment and process deviations. •Provide timely and accurate information of validation parameters established for equipment and facilities. •Acts as liaison with Engineering, Technical Service, and Quality Assurance. •Assist engineers/technicians in the development and completion of validation studies and protocols as needed. •Other tasks as assigned by the company.

*前1~3年工作在「台中廠」培訓，之後開始在「竹北廠」上班。 ●原物料、IPC、產品、安定性樣品、水質之內毒素分析 ●生物活性試驗Bioassay、host cell DNA、host cell protein、sterility等項目例行檢測 (放行檢測、安定性檢測) ●異常事件調查 ●設備維護及校驗執行 ●分析方法SOP制定 ●實驗室LIMS系統 ●其他主管交辦事項

1. 執行例行性、既有產品之非例行性、以及新產品與新產線之確效 2. 執行產品相關之確效評估或研究測試 3. 制、修訂及維護確效相關SOP 4. 協助審閱各部門確效文件 5. 協助技轉專案之管理 6. 其他主管交辦事項

1.具生技藥物製程開發經驗 2.協助產品技轉和製程改善 3.負責執行客戶產程開發專案，管控專案進度，確保各專案符合時程規劃。

1.協助織染日常作業管理與異常處理。 2.負責生產進度、人力與產能數據回報。 3.督導課內5S與化學品儲放管理。 4.支援部門預算資料彙整與日常成本控管。 5.配合公司政策與上級主管工作安排。

1、檢具、治具、輔具設計加工 2、生產製程改善導入 3、協助自動化設備導入

1.藥物分析方法建立、開發及制度建置。 2.實驗室儀器設備之驗證、保養、維護與改善之計劃擬訂與監督管理，確保設備有效運轉，管制良好，功能正常，量測結果符合品質之要求。 3.熟PIC/S GMP規範。 4.其它主管交辦事項。

全新的連續式藥物生產技術， 等著你來挖掘無限的可能性 富田永續生醫科技尋找對於 保養品活性成分、藥物中間體有研發經驗的夥伴， 一起打造次世代連續式智慧工廠的各種殺手級應用 我們相信，一個好的生產方式，一定會搭配先進的連續式生產技術，與好的智慧工廠模式。 我們正在尋找一位對研發充滿熱情與堅持的你，不受傳統窠臼限制，勇於突破現況的特質，能協助找出各種藥物中間體的連續式合成方式，並將製程不斷優化。 這是一份可以參與先進連續式製程與智慧工廠規劃的工作，也能持續深化專業與成就感的研發角色。 工作內容 : 1. 進行藥物中間體合成研究發展，合成條件研發。 2. 以連續式製程合成藥物中間體，協助確認製程關鍵參數，訂定製程操作範圍。 3. 連續式製程優化方向建議，進行良率分析，及試產調配。 4. 原物料資訊搜尋、來源評估與試製。 5. 參與連續式製程的高效反應器研發。 6. 參與核酸藥物的合成與產品開發。 7. 參與和執行GMP 連續式製程確效和設備驗證。 我們希望你具備 • 藥物中間體與藥物開發 相關研發經驗（有 相關品質系統經驗尤佳）。 • 對製程研發有熱情，喜歡與團隊一起協力共事。 • 細心負責，具備創新的想法。 • 基本的跨部門溝通能力，能夠與內部團隊合作，確保客戶需求被妥善滿足。 加入我們的理由 • 專業培訓與發展機會：你將學習到新型連續式生產與智慧工廠的技術方案，提升客戶服務與專案管理能力。 • 與國內外知名企業合作: 我們的低碳永續生產方案受到國內外企業青睞，你將有機會與不同產業的企業客戶合作，拓展人脈與視野。 • 成長晉升機會：我們重視夥伴的發展，團隊全新建立，表現優異者有機會晉升更高職位！