「『保瑞-中壢廠』QA Associate Manager/Manager(Compliance/Supplier Mgt)」的相似工作

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. 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.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.進行原料及成品檢驗之工作 2.執行產品安定性試驗 3.儀器設備驗證與校正作業 4.檢驗方法修訂、撰寫 5.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

• Perform assigned QC work, including routine and non- routine, independently The non-routine work may include method transfer/verificati on/ validation , protocol driven study, or investigations. • Trouble-shooting capability for QC technologies . • Assist in reviewing QC documents including notebooks, datasheets, experimental records, and logbooks • Provide guidance to specialists and lab technicians as assigned • Check the preparations of reagent, volumetric solutions, and test solutions • Perform method verification/ quali ficati on/ validation as required . • Assist in preparing SOP, protocol trai ning, and assigned analytical works

1. 設定/組裝/拆解/清潔 製程設備：例如混合機、造粒機、打錠機及膠囊充填機。 2. 調製藥品主成分及水溶液。 3. 依據規劃排程執行製造生產。 4. 依據優良製造規範及標準作業程序記錄生產活動於批次記錄。 5. 執行主管交付之其他任務。 6. 需配合輪班，早班:08:00~17:00；晚班:16:00~24:00；夜班:20:00~04:00。 7. 週休二日，國定假日休。 8. 產線獎金、輪班津貼、加班費另計，提供供餐(午餐)，有員工停車場。

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

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. 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.Assist in Process Validation and Technology Transfer activities to ensure the accomplishment of company goals. 2.Assist in qualification works for production equipment meeting timeline and cGMP requirement. 3.Coordinate feasibility trials and process validation activities. 4.Prepare study plans, and qualification documentations and/ or batch records assigned tasks. 5.Support production related investigation, CAPA and troubleshooting.

1.無菌作業模擬、可視化煙流驗證；SOP、批次製造紀錄撰寫； 2.從事無菌產品生產準備、生產作業執行、生產流程改善、批次文件審核(包含電子數據) 3.設備驗證、校正、設備保養行程規劃與執行 4.異常處理 5.主管交辦事項

【主要工作內容】 (一)GMP合規之放射性藥品生產（國際級高防護與高氣密性設備）。 (二)GMP合規之放射性藥品之無菌充填（獨特台灣專利鎢罐保護）。 (三)生產設備及儀器維護保養。 (四)生產記錄報表製作與分析。 (五)撰寫工作相關SOP。 (六)其他主管交辦事項。 ※工作須提重物（10公斤） 【加分項目】若您同時具備以下條件很加分。 (一)具藥廠或無菌製劑經驗尤佳。 (二)具二年以上化學實驗或有機合成相關經驗尤佳。 (三)具「輻射安全證書」尤佳。 (四)具「輻防相關證書」尤佳。 (五)放射線相關科系畢業者尤佳。 【專有的工作津貼與獎金項目】 (一)依工作時間計有夜班津貼。 (二)因應公司發展，執行並完成特別專案則另計專案獎金。 (三)「輻射安全證書」證照加給。 (四)「輻防相關證書」證照加給。 ※普瑞默為與國際知名公司合作建置之藥廠，且有專業輻防團隊駐廠指導，能全方位保障所有同仁輻防安全，我們非常歡迎並期待具備相關經驗或有興趣參與台灣核醫製造的您投遞履歷表，讓我們有機會一起聊聊，以尋求彼此合作的機會。 《加入普瑞默生技，與我們一起挑戰世界》

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

Dealing with work related to quality and compliance. 1. Responsible for the follow-up on the corrective and preventive action of deviation report, CAPA form, complaint, internal audit. 2. Assist in the maintenance of the Risk Management and files regarding Quality Deviation/Change Control. 3. Responsible for regional KPI reporting. 4. Perform calibration activities, such as perform calibration/ validation and raise report. 5. Perform temperature mapping activities 6. Oversees warehouse temperature profile, van temperature record, pest control, facility maintenance monitoring. 7. Responsible for preparing validation protocol and summary report. 8. Assignment will be subject to management decision based on department needs. 作業地點有兩個倉庫 (1)高上倉:楊梅區高上路一段150號 (2)龍潭倉:楊梅區梅獅路二段629號 Welcome to submit your application through the DKSH career website. We encourage candidates to submit your resume through the DKSH Career Website and talk with Genie. Applicants who apply via this channel will be given priority in the interview process. 歡迎透過DKSH招募網站投遞履歷 我們鼓勵應徵者透過 DKSH 招募網站提交履歷，並與 Genie 聯絡。透過此管道申請的候選人將在面試流程中獲得優先考量。 https://jobs.dksh.com/job-invite/214547/

1.全廠公用(空調、水、電、氣、鍋爐、蒸汽、 空壓、氮氣、能源管理系統..)設施及設備維 護、修繕規劃及管理。 2.空調系統年度確校再驗證規劃執行。 3.廠區建物、環境、配電維護修繕。 4.生產設備故障排除與維護保養。 5.SOP作業流程、變更管制文件、維護保養計畫撰寫。 6.督導所屬人員及工作執行進度追蹤、人員教育訓練。 7. 具良好溝通協調、資源整合能力。 8.主管交付事項。

1.原料規格與成品規格撰寫 2.執行檢驗規格之方法確認 3.執行實驗室檢驗規格及方法優化 4.建立Excel計算報告模板 5.主管交辦事務 經歷需求 : 需有兩年以上實驗室相關經歷

職務內容 1.儀表合格標籤及免校標籤製作。 2.儀表安裝、參數設定與校正。 3.DCS軟體撰寫及修改。 4.儀控專案的執行。 5.配合新設備製程試車。 6.自動化及儀表的維修。 7.Gamp5文件審閱

1. 細胞治療技術研發與生產團隊之營運管理，確保製程研發、品管、GMP 生產之品質，符合客戶與法規需求 2. 與國內、國外細胞與基因治療公司，建議良好的溝通管道與信任關係 3. 細胞治療製程開發實驗室之管理與營運，確保研發與檢測品質 4. 細胞治療產品 GMP工廠生產製造管理，確保細胞產品生產符合法規與臨床要求 5. 客戶拜訪、接洽，並完成服務案件之簽約。進度與交付事項管理，確保依規劃允收完成 6. 與醫學中心建立合作關係，維持良好的組織來源管道，以建置 TBMC 高品質組織細胞來源與細胞生產種源原料庫建置 7. 持續規劃技術研發，以降低細胞產品成本。例如: 自動化生產的導入，提升生產效率並降低人力成本

-Develop and execute the annual audit plan, covering both Taiwan and North American subsidiaries, with a focus on internal audits and the effective implementation of internal control systems. -Prepare comprehensive audit reports, identifying findings, and closely monitoring corrective actions to ensure continuous improvement. -Oversee the annual internal control self-assessment for the parent company and its subsidiaries. -With a strong sense of audit acumen is required to drive the optimization and enhancement of internal policies, procedures, and compliance standards. -Conduct a project-based audits and support various assignments as directed by management. 1. 年度稽核計畫，包含台灣與北美子公司的內稽與內控制度溝通與推行 2. 稽核報告撰寫，查核發現以及改善情形追蹤 3. 集團母公司與子公司年度內控自評 4. 具備稽核工作敏銳度，內部制度、規範的優化及完善推進 5. 專案查核以及主管交辦事項