「EDE11408_(資深)品保專員_益得廠」的相似工作

1. 了解國內外藥品之查驗登記法規 2. 依國內外查驗登記法規制定檢驗規範 3. 產品查驗登記之評估 4. 相關查登技術文件 5. 國外查登技術文件翻譯 6. 查登專案進度追蹤管理 7. 具溝通、整合能力

1.藥品原料、成品、半成品等理化試驗 2.HPLC、GC、AA、UV、IPC MASS 等分析儀器操作 3.文件、分析筆記、數據統計、報告彙整 4.確效、驗證之檢驗計劃書撰寫 5.確實執行GLP各相關活動 6.水質取樣及檢測環境監控 7.實驗室維護 8.主管交辦事項

1.協助變更評估及偏差事件調查，負責案件審閱及管理。 2.顧客申訴調查。 3.協助品質風險評估與矯正預防措施。 4.供應商評估 5.協助稽核相關作業。

1.偏差調查/實驗室調查/客訴調查 2.變更管制管理 3.供應商稽核與管理 4.安定性計劃撰寫及追蹤管理 5.品質風險管理 6.矯正及預防措施之管理 7.品保查驗登記 8.依國內外查驗登記法規制定檢驗規範 9.其他主管交辦事項

1.品質管理系統: 偏差調查/OOS/OOT、CAPA、變更管制、內外部稽核、客訴管理、人員培訓與資格認證管理 2.供應商管理: 原物料供應商、運輸商、委託合約製造CMO、委託化驗CTL、委託校驗、服務提供者 3.趨勢分析及風險評估 4.產品放行與品質審查 5.設備及設施管理 6.安定性留樣品管理 7.文件管理 8.國內外查驗登記資料彙整 9.執行主管指派的其他任務

1.偏差調查/實驗室調查/客訴調查 2.變更管制管理 3.供應商稽核與管理 4.安定性計劃撰寫及追蹤管理 5.品質風險管理 6.矯正及預防措施之管理 7.其他主管交辦事項

執行原物料、成品樣品分析與安定性計畫 分析儀器校正及檢驗操作 分析方法技術移轉與接收 規格、方法及實驗室相關SOP文件管理 實驗室相關庶務執行與主管交辦事項

1. 產品依據庫存量/訂單等安排生產控管 2. 依據生產目標模擬原物料需求 3. 原/物料請購流程與掌控 4. SAP系統產品基本資料維護 5. 生產異常溝通協調處理

1.執行實驗室相關檢驗：依據檢驗方法執行原料、成品及安定性相關試驗，以及報告覆核。 2.GMP文件撰寫: 變更管制、URS、SOP、檢驗方法、驗證計畫書及各試驗計畫書與報告等。 3. HPLC、GC、ICP-OES…等分析儀器troubleshooting。 4.分析儀器audit trail審閱。 5.管理檢驗設備、試藥及標準品等。 6.協助各類LIR調查。 7. 完成主管交辦事項。

1.負責制定及執行產品與製程的確效計畫，確保符合製藥國際法規。 2.領導團隊，監督品質管理系統的實施與持續改進，確保法規遵循。 3.與跨部門合作，確保產品開發與製造流程符合製藥法規及品質要求。 4.執行內外部稽核，確保符合GMP、PIC/S、ICH等國際標準。 5.分析品質數據，提出改善建議並追蹤法規相關執行成效。

【生產技術人員】 1.藥品/保健食品生產製造(秤量、打錠、膠囊、液劑、膜衣、糖衣、秤料) 2.作業環境及設備的清潔與維護 3.批次製造記錄填寫、領料核對 4.遵循GMP & SOP執行生產作業 【薪資福利】 1.享有技術獎金及績效獎金制度 2.工作期間免費供餐 3.免費汽機停車場

We are seeking a highly motivated and innovative R&D Scientist to join our pharmaceutical development team. The successful candidate will contribute to the design, formulation, development, and optimization of drug products, with a focus on quality, scalability, and regulatory compliance. This role offers the opportunity to work in a collaborative environment with cross-functional teams including Regulatory, Analytical/QC, Quality, Manufacturing, and Business Development. 1.Conduct research and development of new drug formulations for Global Regulated markets (Nasal – Solution, Spray, DPI, pMDI etc.) 2.Follow Quality by Design to plan & execute lab-scale experiments, stability studies, and process development activities including DOE. 3.Responsible for managing monographs, validated excel sheets, approved reports (paper and electronic), notebooks and document archival. 4.Develop & optimize manufacturing processes in compliance with cGMP requirements. 5.Participate in Technology transfer to manufacture pilot, scale up, submission & commercial batches. 6.Prepare technical documents, as per cGMP & ICH for execution and manufacturing including batch records, protocols and reports. 7.Prepare regulatory submission documents as pe ICH including chemistry manufacturing & controls (CMC), product development report, overall quality summary (OQS) etc. 8.Execute CCR, deviation investigation, CAPA, LIR, SOP preparation, internal and support GMP inspection. 9.Stay updated with scientific & global regulatory advancements and ensure knowledge sharing with co-workers. 10.Collaborate with cross-functional teams on project timelines and deliverables

1. To maintain site Laboratory Investigation, Deviation and CAPA Management Systems and perform Track and Trend for deviation & CAPA status and to coordinate deviation investigations related to process during products manufacturing and packaging operations on-site or at CMOs/CPOs. 2. To coordinate Product Quality Complaint investigation/FAR actions and perform Complaint management which involve Track and Trend for complaints status and resolution. 3. To coordinate investigation committee meetings to facilitate discussion to identify impact, root cause(s) in order determine effective CAPAs implementation. 4. To coordinate Annual Product Review reporting activities for the site. 5. To provide support for handling inspection of agency (FDA, TFDA), or external audits from the sponsors/customers. 6. Support SOP revision, daily update of investigation status, quality metrics collection. 7. Other tasks as assigned by the company.

1.保健食品配方設計、試製與製程開發(錠劑、膠囊、顆粒劑、膜衣錠) 2.執行新產品生產技術移轉作業 3.研發報告撰寫、撰寫SOP與其他技術文件 4.主管交辦事項

1.具藥廠或相關產業一年以上之管理經驗 2.可撰寫標準作業程序書及確效文件及生產批次製造記錄

1、QA相關SOP改善 2、相關GMP文件審查 3、所有GMP表單發放及回收 4、製造區環境核准 5、品質系統提升 6、查登資料審查 歡迎 所有求職者

【工作內容】 * 執行原物料、製程、成品之品質檢驗與記錄 * 管理製程中異常狀況，協助追蹤與改善措施 * 協助撰寫與修訂品質相關作業文件（SOP、規範書等） * 執行並維護ISO22000／HACCP／GHP等食品安全管理系統 * 配合主管完成內／外部稽核作業及改善追蹤 * 教育訓練與現場人員品質意識提升 * 客訴案件處理及回報 * 其他主管交辦事項

1.原物料進料驗收作業、報告整理判讀 2.定期環境衛生6S稽核 3.客訴與異常案件調查及處理 4.量測儀器校正及保養維護 5.食品標示審查 6.協助食品追蹤追溯系統資料整理及申報事宜 7.病媒防治管理 8.文件的制訂、審核、生效及變更管理 9.協助公司驗證申請及品保系統執行與管理 10.主管交辦其他相關事項(含內外部稽核事宜..等)

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. 研擬審藥典與食品相關產品資料蒐集、匯整與分析測試的規格建立 2. 熟悉化學／化工原理，與操作化學檢測儀器及檢驗報告結果判讀 3. 開發調整分析方法(HPLC, GC, IC...)，協助產品製程開發過程中，分析方法之確校。 4. 主管交辦事項 ーーーーーーーーーーーーーーーーーーー *熟悉多醣分析相關研究為優先* 勇於接受工作挑戰，能隨公司變革腳步而做應變的人 抗壓性強，能展現績優的執行力 注重團隊合作