「QA Specialist」的相似工作

1. 撰寫及管理品質文件。 2. 規劃及執行品質系統相關之教育訓練。 3. 負責內部及外部稽核活動、矯正預防措施及上市後監督。 4. 收集了解各國法規及標準相關資訊，確保符合法規。 5. 負責產品註冊文件撰寫。 6. 負責與政府法規單位聯絡窗口。 7. 主管交辦事項。 ※擁有相關資深經驗者，薪資面議。

我們正在尋找一位擁有二年以上經驗的法規事務專員，協助處理台灣與歐洲市場的法規業務。理想的候選人需具備堅實的法規背景，並能流利使用中英文進行專業溝通。 工作內容： 1.準備與審核化妝品法規相關文件及標籤資料。 2.確保產品符合歐盟與台灣化妝品相關法規。 3.於產品開發與上市期間提供法規相關支援。 4.審查產品配方，確保成分符合法規規範。 5.熟悉歐盟化妝品法規 (EC) No 1223/2009 及台灣 FDA 法規。 6.具備化妝品配方與成分安全相關知識。 7.細心負責，具備良好的文件處理能力。 *此職位將涉及與法規機構的直接互動，需確保產品遵循所有相關法規。 *化妝品科學、化學、生物化學或相關科系學士以上學歷。 *具備至少 2 年化妝品產業或法規相關工作經驗。

●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。

1.負責實驗室品質管理運作，以確保並提升產品品質為目的，達成公司品質控制目標。 2.遵循國內外藥品主管機關之規範，執行實驗室管制事宜。 3.確保檢驗之文件記錄記載清晰並完整保存，以符合GMP規範。 4.確保分析儀器運作與分析產能達到效益最佳化。 5.指導並管理QC團隊，包括分派任務、培訓與績效評估。 6.跨部門溝通與協調，有效解決品質問題及後續追蹤處理。 歡迎具備製劑廠藥物品管經驗之人才加入。

1. 主導品質事件調查，包括偏差(Deviation)、客訴(Complaint)及不符規範事項(Non-Conformance) ，確保完善調查、正確回應、與及時有效的追蹤處理。 2. 管理、追蹤品質不符合或潛在風險相關的改善行動(CAPA)。 3. 維護並持續優化品質事件調查、CAPA管理、品質相關客訴的流程，確保偏差和客訴發生時備有明確作業指引、並推動矯正預防措施的制訂與落實。 4. 審閱實驗室調查報告(LIR)，必要時推動適當的矯正與預防措施(CAPA)執行、追蹤執行狀況。 5. 支援風險評估作業及例行品質管理會議之召開，將關鍵品質議題彙報予高階管理階層。 6. 協調並參與年產品品質回顧(APQR)之準備與資料彙整，協助品質持續提升。 7. 提供跨部門技術支援，與團隊協作，推動與跟進品質改善計畫(QIP)。 8. 支援公司內部及供應商品質稽核，參與法規及客戶稽核，協助準備資料並追蹤、協調後續因應處理。 9. 協調製程、清潔、分析方法、運輸等驗證作業，確保產品及流程符合法規與國際品質標準。 10.其他主管交辦事項，以確保公司品質管理系統之良好運作。

1. 開發學名藥或新藥的口服固體製劑或者注射製劑之配方。負責指定產品的配方及其製程開發項目。 2. 彙整基本口服固體製劑和注射製劑相關法規 (包括並不限於各國藥典，ICH guideline等)，設計並訂定原料、半成品和成品的規格及化驗SOP。 3. 基本層析(Chromatography)項目的分析方法開發、化驗執行和確效工作 (例如HPLC、GC等)。

1. 審查QA/QC/PD部門技術文件之變更控制，提供有用的意見訊息，以符合法規要求。 2. 與各部門溝通和討論法規現況，並從溝通中獲取訊息用於提交申請。 3. 負責編寫符合法規要求的報批文件。 4. 保持RA部門日常作業順暢。 5. 更新自己和團隊關於當前法規問題、指南。 6. 臨時交辦事項。

Responsibilities: 1.Manage staff in accordance with organization's policies and applicable regulations, including without limitation: planning, assigning, and directing work; managing performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; acting as a coach and mentor for subordinates as they develop in their role. 2.Participate in the selection and onboarding process for new staff by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs. 3.Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable. 4.Monitor updates for regulatory legislations and/or guidelines. 5.Conduct review of documents, procedures, facilities… etc., to ensure compliance to the regulatory requirements. 6.Perform review and quality assurance for reports and documents to be submitted to the regulatory departments. 7.Review the responses of the audit or inspection findings for appropriateness and completeness. 8.By following approved procedure and schedules, conducting audits either independently or collaboratively with other QA uditors. 9.Ensure timely completion of routine QA procedures. 10.Work collaboratively with each department head in the assessment of vendors' qualifications. 11.Assisting in project related or non-project related audits/inspections conducted by customer or regulatory authorities. 12.Write and issue audit reports or any non-conformances form in accordance with SOPs. 13.Ensure that audit findings are clearly made to the relevant project team members, department heads and upper management. 14.Participate in the investigation of non-compliance, problem reporting, or complaint issues. Follow through to verify corrective/preventive actions are appropriate and enforced as well as tracking and monitoring performances of the actions taken before case closed. 15.Perform housekeeping on documents generated as a result of QA activities. Provide inputs to the development of departmental quality system process. 16.Manage SOPs according to company policy or regulatory agencies. 17.Conduct provisional tasks assigned by line manager. 18.Establish training plan for junior QA specialist and provide training to ensure compliance with company policy and regulatory requirements. 19.Perform the tasks assigned by line manager.

【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. 品質系統維護。 2. 製程、品管檢測文件審閱。 3. 偏差調查、變更管制處理。 4. 外部/內部稽核活動。 5. 其他主管交辦事項。

1. 執行細胞治療相關製品之品質檢驗作業 （如：qPCR、微生物限度、無菌試驗、流式細胞分析等） 2. 撰寫與維護檢驗相關SOP、報告與紀錄文件 3. 協助檢驗方法確效、設備校驗與偏差調查等品質活動 4. 支援日常樣品留樣、進樣、記錄管理與異常通報及調查 5. 分析方法確效 6. 品管物料盤點 7. 主管安排執行其他任務交辦

【About the role】 We have an exciting opportunity for motivated individuals to join our CMC team working to develop cell therapies against cancer. The successful candidate will be expected to be a good team player, work with enthusiasm to execute assignments properly. This role is pivotal in translating our cutting-edge research into a robust and scalable manufacturing process, directly impacting our ability to deliver novel therapies to patients. 【Position Title】 Sr. Research Associate / Research Scientist (Process Development) 【Location】 Taipei, Taiwan 【Reports to】 Principal Scientist 【Job Type】 Full-time 【Responsibilities】 • Design and execute experiments for the development, optimization, and scale-up of immune cell manufacturing processes, including cell isolation, expansion, and cryopreservation. • Troubleshoot and resolve process challenges, utilizing a systematic approach (e.g., root cause analysis) to improve process robustness, yield, and consistency. • Evaluate and implement new technologies and equipment (e.g., closed-system bioreactors) to enhance process efficiency and product quality. • Perform cell manufacturing in a cleanroom environment under GTP/GMP guidelines, including meticulous execution of batch records and adherence to stringent aseptic techniques. • Perform in-process controls (IPCs) and product release testing, including cell count, viability, flow cytometry, and other characterization assays. • Author and revise technical documents, including standard operating procedures (SOPs), batch records, and development reports. • Establish the optimized manufacturing processes at the GMP manufacturing site. • Execute and document experiments to support the CMC (Chemistry, Manufacturing, and Controls) section for IND filings. 【Qualification】 • MSc (or above) in life science or related fields (e.g., Immunology, Cell Biology, Bioengineering, Biochemistry). • Minimum of 3 years of hands-on experience in mammalian cell culture with stringent aseptic techniques, preferably with primary human immune cells (e.g., T cells, NK cells). • Hands-on experience with multi-color flow cytometry for immunophenotyping. • Proven ability to work independently in experimental design, execution, and data analysis. • Excellent communication skills and ability to work collaboratively in a team-oriented environment. 【Preferred Qualifications】 • Experience in cell therapy process development, including the use of Design of Experiments (DoE) methodology. • Experience working in a GTP/GMP regulated environment. • Hands-on experience with closed-system cell processing platforms (e.g., CliniMACS, WAVE, bioreactors, cell processing system). • Experience with cell-based functional assays (e.g., cytotoxicity assays, cytokine release assays). • Experience in authoring technical documents such as SOPs or development reports. • Experience with cryopreservation development and optimization.

1. Facilitate 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. Support and ensures the successful day-to-day operations for the company. 3. Perform batch disposition activities in accordance with Lotus' SOPs and within agreed timelines. 4. Ensure the timely review of batch records, SOPs, investigations, corrective actions, change controls, technical documents, and adherence to Quality Agreements. 5. Ensuring that all work is performed safely, with quality, and in a timely, compliant manner. 6. Participating in continuous improvement projects throughout the group and the facility/operational portions of the organization. This includes all QA systems and pocesses as well as those on the shopfloor through the QA on the Floor function

•新產品評估 •規劃協調新產品查驗登記策略、時程與執行。 •規劃產品上市後變更、展延案件之送件時程與策略 •藥品名稱之商標申請與維護 •監督整合規劃eCTD文件之產出 •解決其他部門之法規相關問題 •計劃與執行預算 •監督管理訓練屬員所屬事宜 •輸入藥品之查驗登記(藥品許可證、PMF、DMF) •審核出口國查驗登記所需文件 •藥品許可證生命週期維護：展延、上市後變更

工作詳細內容Job descriptions： Responsibilities & Authorities: ．Responsible for quality oversight and execution and prepare inspection criteria and standards for the assigned projects throughout the product lifecycle and the associated Quality System. Provide QA Approvals/Perspectives as needed. ．Proactively engage with all stakeholders involved with product quality and design transfer. ．Coordinate and oversight the change control process to ensure the process and records are appropriate and accurate. ．Responsible for customer complaint, product return/repair (RMA) and investigations in accordance to client or regulator’s requirements. ．Provide direction for and reviewing and approving deviations, corrective and preventive actions, risk assessments and nonconforming material reports. ．Able to coordinate for tool validation activities and supplier evaluation. ．Able to support process improvements by gap analysis of existing SOPs or processes against up-to-date standards and regulations and updates accordingly. ．Other duties as assigned.

1. 負責依循GMP法規建立品質管制系統和實驗室管理標準 2. 執行QC實驗室的日常管理，確保QC實驗室遵循GMP要求之有效運作 3. 進行樣品檢測，確保檢測資料的正確與完整性 4. 分析方法的開發、技術轉移與驗證，撰寫、審核相關的方案與報告 5. 研究分析影響成品成分、含量、品質及純度之各項因素，並改進之 6. 配合安定性試驗（加速試驗、儲存試驗）、新藥申請之條件制訂有關取樣量、試驗間隔、 試驗法方等標準操作程序，使能決定適當之有效期間 7. QC部門管理，分析方法SOP、品質標準的建立與審核 8. 執行實驗室偏差與變調查，並完成調查報告 9. 樣品委託檢驗協調與聯繫 10. 協助品質相關客訴審核 11. 人員的培訓計畫 12. 需具有化學、微生物、生化等相關基礎 13. 具備英文能力，能撰寫技術文件

Responsible for overseeing the daily operation of Quality Assurance (QA) department, ensuring that all product and processes meet regulatory standards and internal quality requirements. This role involves supervising QA staff, managing quality documentation, supporting continuous improvement efforts, managing both client relationships and specific requirements. 1. Lead and mentor QA team members, ensuring compliance with SOPs and regulatory requirements. 2. Oversee daily QA activities, including product inspections, and release. 3. Ensure all quality processes comply with regulations and cGMP stnadards. 4. Assist in preparing for and conducting internal and external audits. 5. Manage quality records, including batch records, deviations, and CAPAs. 6. Ensure accurate and timely completion of quality documentation. 7. Identify opportunities for process improvements within the QA function. 8. Implement and monitor corrective and preventive actions. 9. Oversee quality aspects of technology transfer and process validation, ensuring that new products meet both regulatory and client requirements.

1.國內外醫療器材產品註冊路徑規劃、申請、變更及展延 2.醫療器材註冊技術文件撰寫、維護及更新 3.確認產品（醫療器材）中英文標示、廣告宣稱內容是否符合法規 4.相關法規、標準、證照申請資料之蒐集/彙整更新及維護 5.產品法規相關法規諮詢 (FDA/EU/ISO/ASTM) 6.產品驗證試驗委外測試及規劃 7.協助業務處理國內外客戶與品質、法規相關資料的收集及回覆。 8.協助品質管理系統的認證維護 9.其他主管交辦事項 本職位的重要性在於確保產品品質與客戶需求相符，並能有效地控制成本和風險。此外，該職位可以通過提高產品品質和供應鏈效率來為公司的發展創造更大的價值。 如果您有相關經驗和技能，請立即申請此職位，我們期待您的加入。

1. 進行樣品檢測，確保檢測資料的正確與完整性 2. 撰寫品管相關文件及各項確效作業 3. 分析方法的開發、技術轉移與驗證，撰寫、審核相關的方案與報告 4. 儀器常規維護及保養 5. 支援公司其它事項及主管交辦事項 **2026年初工作地點:竹北廠區**

1.CMC/CTD 技術審查與建議 從法規觀點審查並提供化學、製造與管制（CMC）文件、原料藥主檔案(DMF)及共同技術文件（CTD Dossier）的技術建議。 2. BA/BE報告文件準備與申請 確認BA/BE報告文件內容，與合作之CRO公司溝通協調，確保資料遞交完整。 3.回應法規查詢與缺件處理 解讀並處理客戶或主管機關於盡職調查（due diligence）或申請缺件階段所提出的技術性法規問題，擬定行動方案與提供科學性說明。 4. 輸入藥品註冊可行性評估 評估輸入藥品產品的註冊可行性，使產品順利進入目標市場。 5. 跨部門技術協作 與研發、生產與品質管理團隊密切合作，解決藥品開發過程中之法規與技術挑戰，確保資料遞交完整、符合時程。 6. 缺件回覆文件製備 撰寫缺件回覆文件，確保回覆內容正確、完整並符合主管機關期待。 7. 法規更新追蹤與內部傳達 追蹤全球法規動態，定期向團隊提供更新資訊，並協助進行內部教育訓練與法規知識傳遞。