「QA Inspector(製程稽查員)_中壢廠 (另有輪班津貼)」的相似工作
BORA PHARMACEUTICALS CO., LTD._保瑞藥業股份有限公司共501筆
10/17
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
10/20
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.
10/14
祥翊製藥股份有限公司藥品製造業
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。
10/20
台灣大塚製藥股份有限公司其他醫療保健服務業
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。
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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！
10/20
台灣大塚製藥股份有限公司其他醫療保健服務業
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
10/16
台灣東洋藥品工業股份有限公司藥品製造業
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
10/17
• 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
09/18
祥翊製藥股份有限公司藥品製造業
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
10/20
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。
10/15
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.
09/25
美時化學製藥股份有限公司藥品製造業
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.
10/15
明台化工股份有限公司藥品製造業
1.維護品質數據、核對檢驗紀錄
2.協助客訴、稽核案件處理調查
3.環境巡檢
4.協助輔導其他部門執行品質改善專案
5.其他主管交辦事項
10/21
金車股份有限公司飲料製造業
1.品管相關檢驗、測試、試車。
2. 需配合工作加班。
3.食品、化學相關科系佳。
4.加班費另計。
5.其他主管交辦事項。
6.歡迎應屆畢業生應徵。
10/16
普瑞默生物科技股份有限公司生化科技研發業
【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》
10/02
祥翊製藥股份有限公司藥品製造業
1. HPLC、GC分析方法開發
2. 安定性試驗設計及報告撰寫
3. 撰寫品質文件
4. 執行ISO與GMP相關業務
5. 協助原料、半成品、成品檢驗業務
6. 協助實驗室校正與維護作業
10/21
10/21
台灣美特精密股份有限公司其他相關製造業
1.使用測量儀器（如：尺規或測微器或三次元等）測量產品的尺寸以符合規格。
2.檢查、測試或測量材料、產品、裝置。
3.掌握品質變異產品異常回報。
4.氣密測試。
5.其他主管交辦事項
*無經驗可，可進行培訓
*固定週休六日，需可配合平日或假日加班，加班費另計
10/21
藝珂人事顧問股份有限公司人力仲介代徵
"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!
10/20
台灣大昌華嘉股份有限公司其他醫療保健服務業
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/