「品質驗證(資深)專員 QU Validation (Sr.) Specialist」的相似工作

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. - Analytical Method Development: Perform analytical method development, formulation screening, finished product testing, stability study, dissolution testing, RLD reverse engineering, technical transfer, and laboratory-related work during the development stage. Support NDA and ANDA submission. Support the complete drug development lifecycle management. 分析方法開發- 主要職責包括以下內容: 在開發階段進行分析方法開發、配方篩選、成品測試、安定性研究、溶出度測試、原廠藥逆向工程、技術轉移和實驗室相關工作。協助NDA和ANDA查驗登記。協助完整的藥物開發生命週期管理。 - Method Validation: Perform analytical method validation, analytical method verification for drug substances, finished products, cleaning analytical methods. Conduct method transfer. Support raw material and stability analysis. Support NDA and ANDA submission. 方法驗證: 執行原料藥、成品、清潔分析方法的分析方法確校、分析方法確認。執行方法轉移。協助原料和安定性分析。協助NDA和ANDA查驗登記。 2. Train, lead, mentor and supervise team members in day-to-day laboratory operations. Support relevant departments and customers to complete projects on time. Ensure all activities and analysis comply with GMP, correct procedures, policies, and health and safety regulations. 在日常實驗室操作中，訓練、領導並監督團隊成員。協助相關部門和客戶按時完成專案。確保所有活動和分析均符合藥品良好製造規範、正確的程序、政策以及健康和安全法規。 3. Responsible and accountable for the quality and timeliness of the project deliverables, resource management, technical support for team members, and communication of the progress to the senior management. 對專案交付的品質和及時性，資源管理，團隊成員的技術協助以及與高級管理階層的進度溝通負責並承擔責任。 4. Manage and lead day-to-day operations with the team, including prioritization, task assignment, workload management, and risk management. 與團隊一起管理和領導日常運作，包括優先順序調整、任務分配、工作負荷管理和風險管理。 5. Adequately utilize and maintain analytical instruments/equipment. Diagnose and identify solutions to resolve analytical instrument issues. Perform calibration, qualification, and preventive maintenance. Support for procurement and qualification of new analytical instruments/software. 充分利用和維護分析儀器/設備。診斷和識別解決方案以解決分析儀器問題。執行校正、驗證和預防性維護。協助採購和驗證新的分析儀器/軟體。 6. Review the documents, electronic records. Prepare analytical protocols and reports, and CMC documents. Monitor data trending and support for deficiency letter response. Ensure good documentation practices and data integrity. 審查文件、電子記錄。準備分析計畫書和報告以及化學製造管制文件。監控數據趨勢並協助缺失信件回覆。確保優良文件化規範和數據完整性。 7. Lead and support CCR, deviation investigation, CAPA, LIR, SOP preparation, internal and GMP inspection。 協助變更管制、偏差調查、矯正預防措施、實驗室調查報告、標準操作程序準備、稽核。 8. Responsible for managing monographs, validated excel sheets, approved reports (paper and electronic), notebooks, and scan copies. 負責管理檢規、經過驗證的Excel工作表、已批准的報告（紙質和電子版）、筆記本和掃描副本。 9. Support assigned responsibilities to maintain GMP compliance of the chemical laboratory, as applicable. 如適用，依據分配責任，維持化學實驗室運作皆符合藥品良好製造規範。 10. Transfer analytical method to Quality control, QP sites, and other receiving laboratories. 轉移分析方法到品質管制，QP所在地和其他接收實驗室。 11. Lead and guide laboratory management work, e.g., reference/working standard management, instrument management, laboratory area cleaning, reagents and solvents, and other supporting systems. 領導和指導實驗室管理工作，例如參考/工作標準管理、儀器管理、實驗室區域清潔、試劑和溶劑以及其他支援系統。 12. Stay informed with the latest industry trends, techniques, and best practices. 隨時了解最新的行業趨勢、技術和最佳實踐。 13. Perform literature search, patent landscape review, regulation comparison, review guidelines, read the pharmacopeias, technical document to understand the latest knowledge of the pharmaceutical industry. 進行文獻檢索、專利態勢審查、法規比較、審查指南、閱讀藥典和技術文檔，以了解製藥行業的最新知識。 14. Ensure the laboratory Capex management. Review & approval 0f URS, DQ, IQ, OQ, PQ & Vendor qualification. 確保實驗室資本支出管理。 審閱和批准 URS、DQ、IQ、OQ、PQ 和供應商資格。 15. Promptly complete work and tasks assigned by the supervisor 及時完成上級下達的工作和任務。 16. Motivate and empower team members. Conduct performance review and appraisal for team members. 激勵和授權團隊成員。執行績效審查和評價。 17. Engage with the team and manage the conflict, making sure individual employees into a cohesive team and complete the project milestone. 與團隊互動並管理衝突，確保員工個人成為一個有凝聚力的團隊並完成項目里程碑。

1.開發調整分析方法(HPLC, GC, IC...)，協助產品製程開發，分析方法之確校 2.執行實驗室設備3Q 3.研擬審查藥典相關產品規格及分析測試，建立藥典規格 4.操作化學分析儀器進行分析，協助產品放行

※※※擴大徵才，工廠提升計畫完工，製藥產線擴大生產規模※※※ 依廠內標準作業程序和現行GMP規範，按排程和製造批次執行產品製造，工作內容包含： 1. 負責執行產品生產相關工作 2. 負責執行產品之製造 3. 負責生產進度及狀況，確實填寫批次記錄及相關表單 4. 執行設備及工作環境清潔及維護 5. 製程設備操作 (混和、打錠、造粒、充填、熔膠、壓丸、定型乾燥等)及相關GMP文件記錄填寫 6. 包裝機台操作(片裝、瓶裝、盒裝、裝箱等)及相關GMP文件記錄紀錄填寫 7. 其他主管交辦事項 加入我們的美時製藥產線團隊，讓您的技術熱情得到最大發揮！ 您將獲得製藥工藝和高品質生產技術的完善訓練及升遷制度，立即加入我們，美時是您製藥成就發展之路的唯一選擇！

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.原料、成品之一般檢驗及微生物檢驗 ，以確保品質符合公司規範。 2.執行公司產品的可靠度測試，並分析問題，以找出造成產品可靠度問題的關鍵因素。 3.生產線巡檢、環境監控及機具設備衛生檢查 。 4.檢測數據統計、分析與資料歸檔 。 5.執行內部衛生稽核 。 6.具有HACCP(Hazard Analysis Critical Control Point 食品衛生安全重點控制) 60A、60B證照者，優先錄取。 7.其它主管交辦事項。

*前1~2年工作在「台中廠」培訓，之後開始在「竹北廠」上班。 ●環境與水質採樣及其相關檢驗，微生物/內毒素試驗分析 ●微生物鑑定 ●執行空調系統驗證與水系統驗證 ●培養基效能驗證、高壓氣體採樣 ●微生物檢驗/監測異常事件調查 ●設備維護及校驗執行 ●分析方法SOP制定

1.Perform process validation in accordance with company and regulatory requirements. 2.Prepare and revise production Master Batch Record for process validation and commercial. 3.Execute manufacturing process. 4.Prepare data summary and reports. 5.Other duties as assigned, such as shipping study, bulk hold study, and packaging validation.

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.供應商品質管理 2.廠內品質異常處理 3.制定品質標準(SIP) 4.客訴處理追蹤 5.開發專案執行 6.主管交辦事項 SQE工程師是公司生產過程中至關重要的職位，其在提升產品品質、確保生產線順利運作等方面發揮著關鍵作用。隨著製造行業的發展，SQE工程師擁有著良好的發展前景和職涯發展空間。 如果您擁有以上相關經驗和技能，並且對我們公司的職位感興趣，歡迎投遞履歷，我們期待著您的加入！

1. Establish a stability database for annual product reviews and product attribute statistics. 2. Stability program management 3. Supplier qualification, internal audits 4. Monitor and implement cross-contamination prevention measures 5. Cleaning validation and verification management 6. Assign as requested by supervisor. 該員工主要負責APR (stability section), Stability program management, shipping study

1、PIC/S GMP品質系統規劃、建立與運作管理 2、GMP流程與相關表單建立 3、管理廠房設施儀器設備的驗證/確效/校正工作 4、協助公司建廠品質系統規劃 5、品質系統文件撰寫與維護 6、執行GMP管理系統(例如：變更管制、偏差調查、、等等) 7、執行GMP教育訓練 **2026年初搬遷_工作地點:竹北廠區**

*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. 產品開發 (製劑研究開發與執行、開發時程控管與執行) 2. 技轉放大試製 (GMP文件準備、至工廠進行放大試量產或查登批、相關流程作業與協調) 3. 安定性試驗、製程確效等作業 4. 協作查驗登記與法規文件準備（CTD Module） 5. 評估製劑資料，解決異常問題並提出風險控管建議 6. 與分析部、QC、QA、生產等部門跨部門合作，確保產品開發進度與品質目標 7. 建立與維護實驗室管理制度

1.蛋白純化，包括柱填充、緩衝液製備與GMP生產。 2.純化製程放大與GMP生產。 3. GMP相關之製程確效、廠房/設備維護及文件建立等工作。 4.其他主管交辦事項

【工作職責與內容】 • 執行原物料、半成品、成品抽樣與檢驗。 • 批次紀錄審核與歸檔。 • 進行環境監測與紀錄維護。 • 協助處理不合格品原因分析與改善追蹤。 • 品質制度維護與檢驗方法更新。 • 完成主管交辦事項。 【Job Description】 • Perform sampling and inspection of raw materials, semi-finished, and finished products to ensure compliance with quality standards. • Review and archive batch records. • Conduct environmental monitoring and maintain records. • Assist in root cause analysis and corrective actions for non-conforming products. • Participate in quality system maintenance and inspection method updates. • Carry out tasks assigned by the supervisor. 【具備條件】 • 再生醫療相關資歷5年以上。 • 積極主動的工作態度與良好溝通能力。 • 享受團隊合作，能夠與不同專業的夥伴共同創造突破。 • 若擁有外泌體相關實驗經驗，將是加分項！ 【招募流程】 • 第一關：書面審查 — 先審閱您的履歷與相關資料，符合資格者將安排面試。 • 第二關：部門主管與人資面試 — 與您聊聊工作經驗、專業能力及合作方式，讓雙方更了解彼此。 • 第三關：高階主管面試 — 安排測試或小測驗，了解您的專業能力和相關背景。 請將論文資料mail至以下信箱，進行初步書審，符合資格者，再行通知面試。 e-mail : dafanhealth@gmail.com 【我們期待你的加入！】

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.

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

1. Utilizing strategic sourcing process to identify, negotiate and implement packaging materials, indirect materials, procurement initiatives to drive cost savings. 2. Align with sourcing team to provide local business requirements and market information to support effective collaborative regional strategy creation and execution 3. Partnering with RD / RA/ NPL, and other Functional groups (Executives, Quality, R&D, Regulatory Affairs, Finance, Legal, Engineering….) in discovery, contract negotiation, optimizing economic value, on-time delivery of product & services, cost management & reduction, supplier & partner risk mitigation, and scope of work development. 4. Develop and implement forward thinking procurement strategies to both optimize spending and minimize risk. 5. Creation of effective preferred supplier program and instillation of organizational discipline on onboarding new vendors. 6. Development of KPIs for strategic sourcing with cyclical delivery which drives continuous improvement. 7. The primary work location for this position can be based in Taipei or Taichung offices, in addition to the Nantou site. The incumbent is required to work on-site at the Nantou facility at least 1 to 2 days per month, subject to business needs.

1. 品保團隊部門管理、績效管理、工作指導、問題分析。 2. 負責公司醫療器材品質系統的建立及維護。 3. 孰悉風險管理及人因工程管理，可規劃並執行相關要求。 4. 改善產品信賴度、可靠性、品質，進而全面提升產品品質。 5. 擅長品質系統管控與應變承擔之高績效品管人才。 *薪資與職等將依您的能力與經驗彈性敘薪。