「品質保證經理/副理 Quality Assurance Lead」的相似工作

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. Ensure the timely review of batch records, SOPs, investigations, corrective actions, change controls, technical documents, and the adherence to Quality Agreements. 2. Establish meaningful goals and metrics for groups in conjunction with the Function Lead, and manage the performance to those goals. 3. Ensure that all work is performed safely, with quality, and in a timely, compliant manner. 4. Manage and/or participate in the investigation of non-conformances and follow-up corrective/preventative actions in compliance with quality procedures, policies, and regulations. Ensure the group is doing the same as required. 5. GMP Compliance Oversight: • Oversee the GMP Vendor Audit Schedule. Ensure vendor and auditor availability (internal/external/consultant), and confirm audit dates with both auditors and vendors. • Review supplier audit reports, ensuring they meet Lotus QA standards and are compliant with Lotus SOPs. • Request documented evidence of closure when necessary, and file both electronically and in hard copy. • Review vendor audit responses and manage the review/editing cycle until responses are acceptable. • Submit observation reports to vendors, communicate response timelines, and track them to ensure timely responses. • Submit observation reports to customers/regulatory bodies, communicate response timelines, and track to ensure timely responses. • Ensure regulatory compliance from both dossier and site operation perspectives. 6. Quality Assurance Management: • Documentation control (e.g., master batch record, specification, and method) • Investigations, complaints, deviations, CAPAs, APRs

1. To establish training curricula in accordance with requirement of manufacturing activities, including manufacturing technology, GMP concepts and other working guidelines. 依照製造活動之需求建立訓練課程，包含製造技術、GMP概念與相關工作規範。 2. To establish wide variety of training materials, including SOPs, training slide deck, training video, testing questions and training checking list. 建立各種類型之訓練教材，包含SOP、訓練簡報、訓練影片、課程考題與訓練檢核表。 3. To optimize the current training materials, including revision of SOP, updating of slide deck and editing of training video. 針對現有的訓練教材進行優化，包含SOP改版、簡報更新與訓練影片製作。 4. To conduct effective induction and orientation sessions. 執行有效的新進人員培訓課程。 5. To conduct training activities in accordance with the training program, including newcomer training, SOP training, on-the-job training (OJT), and training activities related to GMP production. 依照訓練計畫執行訓練活動，包含新人訓練、SOP訓練、OJT與GMP生產相關之訓練活動。 6. Compile training document records and save them to training management system and assist in maintaining the training curricula in the training system. 彙整訓練文件紀錄保存至訓練管理系統並且協助維護訓練系統之訓練課程內容。 7. Other works assigned by manager. 其它主管交辦事項。

1. Provide Quality Assurance support and/or lead projects in line with Alvogen/Lotus guidelines, procedures, cGMP, and ISPE guidelines and regulations related to authoring, executing, reviewing, and approval of specifications and validation documentation as appropriate according to the Validation Life Cycle, including but not limited to: - Validation Plans/Protocols - User Requirement Specification (URS) - Risk Assessment (RA) - Functional Specification (FS) - Configuration Specification (CS) - Design Specification - Commissioning - DQ, IQ, OQ, PQ - Summary reports - Requirements Traceability Matrix (RTM) - Periodic Review, etc. 2. Liaise and coordinate with all departments and relevant key stakeholders (QA/QC, Manufacturing, Engineering, R&D, Regulatory Affairs, IT) in providing quality assurance support for the Validation program. 3. Communicate validation approaches and requirements during audits if applicable. 4. Facilitate a continuous improvement culture with all departments (QA/QC, Manufacturing, Engineering, R&D, Regulatory Affairs, IT). 5. Provide Quality Assurance support for technical problems that impact products and processes. 6. Provide Quality Assurance support in regards to computerized systems and collaborate with equipment owner(s) to ensure the initiation and implementation of change control activities are in accordance with site procedure. 7. Provide Quality Assurance support in regard to deviations/exceptions during qualification activities. 8. Assist in the development of training material for qualification activities. 9. Serve as a Subject Matter Expert to support the organization in maintaining a work environment focused on quality and one that fosters learning, respect, open communication, collaboration, integration, and teamwork. 10. Manage Validation contractors to complete on-site validation, if required. 11. Lead and participate in cross-functional teams as defined by the site management team. 12. Must be able to maintain a “big picture” perspective without losing sight of the details necessary to meet deliverables and deadlines. 13. Interpret Regulatory Authority regulations, guidelines, and policies. 14. Communicate and ensure compliance with Quality objectives, policies, and procedures.

1.西藥製藥廠QC主管經驗。 2.綜理日常原料藥、成品檢驗、水系統及環境監測之執行確效活動之檢驗及其COA之準備。 3.QC SOP之撰寫與更新&OOS及Deviation事件之調查及CAPA擬定。 ---------------------------------------------------------------------------------------- 選擇Otsuka，與世界級的製藥職人共創未來！ ~~中壢工廠特有福利~~ 一、優渥薪資與福利 1. 保證14個月年薪，盈餘時發放年度紅利獎金。 2. 免費中餐、加班誤餐費、全新員工餐廳即將改建，舒適又貼心。 二、健康與生活平衡 1. 優於法令的年度健檢，專業醫護及免費心理諮詢，全面守護身心。 2. 豐富的CSR公益活動、家庭日、員工旅遊、春酒/尾牙，樂趣無限。 三、便利交通與穿搭 1. 免費機車停車位，中壢工業區稀有免費汽車停車位（每年抽籤）。 2. 提供冬夏Polo衫及外套當工作服，出門即有型，穿搭無煩惱。 四、國際職涯發展 全額補助海外研修，前往日本、越南、韓國、西班牙等地，拓展全球視野。 立即投遞履歷，成為Otsuka的一員！

1. 負責全廠品質制度之規劃與執行,以確保系統與產品符合國際GMP及PIC/S法規要求。該角色的範圍還包括品質預算和資源規劃、品質績效指標/品質看板、品質策略規劃、品質目標和品質特定項目。 Responsible for planning and implementing the factory quality system to ensure that the system and products comply with international GMP and PIC/S regulations. The scope of this role also includes quality budget and resources planning, quality performance metrics /quality dashboards, quality strategic planning, quality goals& objectives, and quality-specific projects. 2. 品質系統Quality Management System - Oversee Quality Management System (QMS) activities such as customer complaints handling, deviation management, CAPAs, change controls quality risk management, etc. ensuring they are timely and effectively executed. 3. 法規系統Compliance System- Oversee and support supplier quality management program, documentation management, and training management in medical quality. 4. 稽核和查廠Audit and Inspection- Coordinate self-inspections and support regulatory authorities' inspection/client audits. 5. 品質績效指標Quality KPI - Monitor quality-related metrics ensuring their compliance with the site targets and host quality councils. 6. 跨部門活動/專案管理Cross-function activities/projects- Support cross-function activities/projects when required ensuring quality regulations and requirements are followed. 7. 主管交辦事項Assigned by supervisor

The Quality Assurance Specialist provides critical support to the QA Manager in ensuring GMP compliance across all external suppliers and internal laboratory operations. This role assists with tracking, monitoring, and coordinating quality activities while supporting the review and management of GMP documentation from API suppliers, excipient suppliers, CMOs, CPOs, and contract service providers. Documentation Support and Management • Assist in the review and processing of GMP documents including deviations, LIRs, change controls, and complaints • Track document review timelines and ensure timely completion of quality assessments • Maintain organized filing systems and document control databases • Prepare preliminary document reviews and summaries for QA Manager approval Supplier and Contract Service Provider Monitoring • Monitor compliance status and performance metrics for API suppliers, excipient suppliers, CMOs, CPOs, and contract service providers • Track supplier audit schedules, findings, and corrective action completion • Maintain supplier qualification status records and renewal schedules • Assist with supplier communication and coordination of quality-related activities Laboratory Quality Support • Assist with tracking and monitoring of laboratory analytical results and trending • Support method validation activities by organizing protocols, data, and reports • Monitor instrument qualification schedules and maintenance activities • Track laboratory investigation timelines and CAPA implementation Quality System Administration • Maintain quality management system databases and tracking tools • Generate routine quality reports and performance metrics • Support CAPA tracking and implementation monitoring Project Coordination and Communication • Coordinate meetings, follow-up activities, and action item tracking • Assist with cross-functional project support and quality deliverables

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。

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

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。

【職務內容】 1. 品質系統(ISO/NSF/BRC等)的維護建立與認證，並確認現有系統的有效性 2. 內/外部品質相關之稽核執行並確認其改善成效 3. 工廠各部門品質管理系統SOP建立，有效預防未來品質問題 4. 協助品質相關客訴審核與真因改善 5. 協助執行認證系統中部分確效，如國際品質相關認證 6. 與同仁合作海外工廠品質系統建立；需具備優異英文能力 (例如：TOEIC 800分以上)

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.負責相關專案工程執行及能獨立作業充份了解每個廠務系統做好維護作業。 2.配合執行溫度及濕度均勻度測試。 3.負責供應系統: 空調系統、冰水主機、純水、CDA運轉及維護保養,以及緊急搶修、管理外包商執行細項，並針對現況提出良好的改善方案。

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. 留樣品/安定性管理。 2. 製造批次審核、COA COC發行。 3. 生產製程中IPC取樣。 4. 產品異物檢查。 5. 其他主管交辦事項。 其他條件 1. 具藥廠QA經驗者優先GMP針劑/固型劑生產製造流程佳。 2. 外語能力聽/說/讀/寫中等或以上，具抗壓性，溝通協調能力。 3. 需要經常進產線更衣。 4. 視力需要配合矯正到公司規定。 5. 熟悉Office操作。

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.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. 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. 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.

●加入我們，成為推動數位化實驗室的關鍵力量！ 【LIMS 系統配置工程師】｜專為醫藥產業打造的合規資訊解決方案 你是否曾在QC或檢驗實驗室中，感受到繁雜紙本與手動流程的低效率？ 你是否想更深入參與實驗室數位化的轉型，從「使用者」變成「設計者」？ 如果你有理科背景、熱愛解決問題，並對資訊系統充滿好奇，那你就是我們要找的人！ ●我們在做什麼？ 我們是一家專注於醫藥產業合規資訊系統（如LIMS、MES、eBR、QMS, TMS, DMS）的導入服務公司，客戶涵蓋台灣及亞洲多家知名藥廠，已服務百家GMP藥廠，包含亞洲TOP500跨國藥企。 我們的使命是協助藥廠數位轉型，導入高效、合規且符合GMP要求的資訊平台。 ●你將負責的工作內容 作為LIMS系統配置工程師，你將參與實驗室資訊系統的全生命週期，包括： 1. 專案導入與系統實施 -協助專案規劃與需求分析（與客戶QC或實驗室端人員溝通） -執行系統組態（設定工作流程、樣品管理、檢驗項目等） -撰寫與執行驗證文件（如OQ/PQ測試腳本） 2. 客戶教育與支援 -培訓使用者並進行系統操作教學 -協助解決客戶實際操作中的問題 3. 售前技術支援（可逐步參與） -協助顧問團隊提供專業建議與解決方案建議 ●我們希望你具備以下背景 -有藥廠QC部門或檢驗實驗室工作經驗 -熟悉GMP/GLP環境的作業流程與品質規範 -喜歡解決問題、邏輯清晰，對系統導入或程式有興趣 -樂於與人溝通、願意學習新的工具與流程 ●加分條件（非必要） -曾參與過LIMS、ERP或其他實驗室/工廠系統導入專案 -具備GMP電腦化系統驗證概念（CSV） -能獨立撰寫操作手冊、測試報告或教育訓練教材 ●你將會怎麼工作 -與公司內部顧問、開發工程師及客戶端的QA/QC/IT團隊協作 -任務導向，培訓後能獨立負責中小型LIMS模組導入 ●為什麼加入我們？ -你將真正了解「藥廠如何數位轉型」，從內部流程到系統設計一手參與 -們擁有經驗豐富的教育訓練與知識分享制度，讓非資訊背景的人也能學會系統實施 -你的QC/實驗室經驗，會是推動產業變革的珍貴資產 ●工作地點 -台北市大安區（可配合專案短期出差） ●歡迎與我們聯繫！ -請將你的履歷直接在104/官網投遞。