「【中壢工廠】Quality Management Section Chief 品質管理部QC課長」的相似工作

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

1.熟悉 PIC/S Annex 1 對無菌製劑的要求 2.了解Contamination Control Strategy（CCS）與風險管理概念 3.現場品質監控 4.批次審閱與放行支援 5.品質系統運作與異常調查　 6.產品品質檢討（PQR） 7.稽查應對與品質保證支援 8.品質風險管理與污染控制策略（CCS）參與 9.文件與報告審閱 　

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. 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.製品出入庫作業 2.原物料出入庫收發作業 3.倉儲環境清潔維護及防蟲鼠相關作業規範執行 4.其他主管交辦事項 ※輪班津貼另計

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

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.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

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.

【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》

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

☀️上市櫃台灣知名藥廠 培育長期正職人員 ☀️中壢工業區 稀有職缺 周休建紅休固定班☀️ ☀️訂單穩長期工作 月入三萬起外加獎金最高三千☀️ ☀️免費機車車位 周休六日 見紅休☀️ ➡️ 工作內容： 生產技術員：調製、秤量、充填、滅菌 、QC品保 ➡️ 工作地點： 中壢區吉林路 (中壢工業區) ➡️ 工作時間：【全新廠區 無菸環境無塵室環境乾淨冷氣特強】 1.日班：08:00~16:00 2.中班：16:00~24:00 3.夜班:24:00~08:00 4.薪資&上班時間【可固定班可兩班輪(輪班隔週輪) 【早班】08:00~16:00 月薪31000起 【中班】16:00~24:00，交通津貼50/天，輪班津貼220/天 月薪36940起 【夜班】24:00~08:00，交通津貼50/天，輪班津貼370/天 月薪42000起 ➡️ 薪資待遇：本薪30200+全勤800，月薪31000 ~38000起薪 (績效獎金另計0~3000/月)加班費另計 ➡️ 休息時間：30分鐘，上下間休30分鐘 ➡️ 用餐說明：僅早班免費供一餐 (加班超過18:00有誤餐費65，超過20:30再加30) 中班誤餐費130/天、夜班誤餐費130/天 ➡️ 休假制度：周休六日 見紅休 ➡️ 工作條件：走動性久站、無塵服、搬重物、須配合加班 ➡️ 停車位：免費機車停車位 <正職>另有期滿獎金、績效獎金0~3000/月 月薪28990(含全勤)+津貼，均薪31000~45000 【正職福利】 ￭ 獎金福利：年中、年終獎金、員工紅利、資深員工獎勵 ￭ 保險福利：勞保、健保、團保 ￭ 補助福利：福委會旅遊津貼、交通津貼、結婚禮金、年度健檢 ❣️【快速預約✚找康彼斯柔伊】❣️ ☑️【線上投遞履歷，將立即與您聯絡】 ☑️【請電洽☎0911608280(手機號碼搜尋加Line)，找柔伊面試】 ☑️【LINE】@661pongj【請留下 姓名✚電話✚職缺名稱】

"國際製藥大廠，穩定發展，正職獵才機會" 將支援公司品質保證與品質控制相關作業，工作橫跨實驗室操作、 品質系統管理、供應商與倉儲管控，是企業品質穩定運作的核心角色!!! 工作內容: 1.具備西藥製藥廠 QC 主管經驗。 2.綜理原料藥、成品檢驗、水系統及環境監測之執行與確效，並負責 COA 準備。 3.QC SOP 撰寫與更新，OOS 與 Deviation 事件調查，以及 CAPA 擬定與追蹤改善。 4.具備實驗室儀器操作經驗，熟悉 PIC/S GMP 規範。 福利制度: 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。 3.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）。 4.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。 若您對品質把關有熱忱，並具備實驗室操作與紀律執行力， 這將是您在國際藥廠職涯邁進的重要一步！ 也歡迎更多Q高階主管投遞詢問，若有合適職務也會同步分享給您!

Introduction to the job Do you like challenges and do you want to work in a fast pacing supply chain environment to support some of the biggest semiconductor companies worldwide? Are you familiar with Logistics Operations and like to managing urgent demands on a daily basis?  If this sounds like you and if you have a strong customer oriented mindset, here is your mission. Role and responsibilities For our Global Operations Center in Taiwan we are searching for Supply Chain Professionals. You fulfill the demand of our customers for spare parts and tools for their maintenance activities on some of the most complex machines in the right quantity and at the right time & cost. Time is of the essence to ensure a seamless production of our customers without interruptions on our machines. -Handling of urgent material requests from worldwide customers in a rolling 24/7 shift system with the right customer focus, while meeting all milestones related to communication and execution -Monitoring of worldwide shipments  -Ability to resolve complex issues and drive improvements to further optimize processes -Ability to support escalations and provide communication proposals for review -Constructive and reliable communication with worldwide stakeholders from all departments within ASML -This position requires shift work. Education and Experience Bachelor's Degree in related subject i.e. Supply Chain Management, Information Science, Engineering etc. preferred -Minimum 1 year of relevant experience in an international company, semiconductor industry is preferred -A tactical thinker with strong interpersonal and communication skills -Analytical thinking and ability to organize and prioritize workload Skills Working at the cutting edge of tech, you’ll always have new challenges and new problems to solve – and working together is the only way to do that. You won’t work in a silo. Instead, you’ll be part of a creative, dynamic work environment where you’ll collaborate with supportive colleagues.  There is always space for creative and unique points of view. You’ll have the flexibility and trust to choose how best to tackle tasks and solve problems. To thrive in this job, you’ll need the following skills: -Stress-resistant; act under high pressure -Flexible; willing to go the extra mile for the customer -Excellent professional communication in English, written and oral -Drive for results; does not stop until solution has been found, even when obstacles arise -Team player -Change management competencies -Convincing, pro-active and “can do” mentality -Cultural awareness -Experience with ERP system(s), SAP R/3 knowledge preferred -Ability to prioritize Diversity and inclusion ASML is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, veteran status, disability, sexual orientation, or gender identity. We recognize that diversity and inclusion is a driving force in the success of our company. Need to know more about applying for a job at ASML? Read our frequently asked questions.

1.藥品,健康食品及保健品等微生物限量檢驗及一般物理檢驗 2.廠區水質分析(含微生物)檢驗 3.藥食品分析設備校正 4.執行藥食品安定性試驗

1.西藥原料,半成品,成品化驗（微生物試驗） 2.安定性試驗分析 3.化驗規格及方法維護 4.儀器確效及核驗 5.完成主管交辦事項

1. 負責化學藥品、原物料進料檢驗 2. 負責高分子、離子交換樹脂製程中品質檢驗 3. 負責高分子、離子交換樹脂出貨品質檢驗 4. 負責量測設備校驗 5. 製作及維護檢驗品質紀錄 6. 維護統計製程管制(SPC)運作

▶ —【請直接打電話或加Line聯絡】— ◀ ⭐ 連絡電話 : 0979051866 ⭐ 官方帳號 : https://lin.ee/jVYoe5J ★ 加入後請幫我留姓名 / 電話 / 截圖職缺文 ★ - 倉管組會到中和廠受訓 // 有專車直達 生產組固定在中壢廠 需做供膳體檢 // 需二面 - 工作內容： 生產組： 肉品蔬果食材清洗、包裝、備料、調味、簡單顧機台作業 ( 需著無塵服作業 ) --- 倉管組：食材進貨、理貨、分貨 ( 無需著無塵服作業 ) - 工作時間： 生產組： 時間 07 : 30 - 16 : 30 / 09 : 00 - 18 : 00 生產固定在中壢廠 --- 倉管組： 中壢廠正式時間 06 : 00 - 15 : 00 固定出勤日：週二、四、六、日 每週額外安排 1 天出勤，總計每週出勤 5 天 - 休假制度： 排休 - 薪資: 時薪：210 月'薪：33'000 ~ 40'000 ( 視經驗能力核薪 ) (( 可選時薪或月'薪 )) - 工作地點: 中和區連城路222巷 ( 受訓地方 ) 中壢區新北園路

1.執行工廠PICS/GMP品質政策 2.抽樣與管理及申請抽驗送檢 3.執行校正與管理 4.執行確校與文件管理 5.建立SOP維護與管理 6.變更管制制追蹤與管理 7.安定性試驗計劃執行與管理 8.其他交辦事項