「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500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.
10/20
製程管制及取樣、品保記錄維護
1.依不同製程需求執行製程管制活動
2.原物料取樣及檢查
3.純水/自來水水質取樣
4.清潔確認及確效取樣
5.文件紀錄及數據管理
6.其他如主管交付工作任務
7.需視需求配合輪班，週休二日，國定假日休。
8.輪班津貼、加班費另計，提供供餐(午餐)，有員工停車場。
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。
10/22
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.
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
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。
10/17
• 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
10/16
品元實業股份有限公司其他食品製造業
1.執行食品相關檢驗實驗並記錄檢驗結果，並能操作實驗及管理實驗室庶務。
2.負責樣品留樣管理，包括樣品保存、標籤紀錄及定期檢核。
3.整理及維護品保相關文件、檔案與數據，確保數據準確與及時性。
4.蒐集食品相關檢驗方式及法規等。
5.協助完成部門交辦的其他品保相關行政工作。
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.
10/21
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
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》
10/20
健喬信元醫藥生技股份有限公司藥品製造業
1. 職責與職位要求：
*審查NDA/ ANDA製劑相關文件，確保其符合國際和地區監管標準
*與內部團隊協調，確保產品的合規性和註冊進度
*熟悉各國監管要求，確保提交的文件遵守各地的法規
*參與審查過程中的跨部門協作，確保項目的有效執行
2. 資格與技能要求：
*具藥學、化學或相關領域背景
*至少有1年以上的藥品審查經驗
*了解國際藥品監管要求，包括ICH、FDA、EMA等
*強大的問題解決和溝通能力，能夠應對複雜的監管挑戰與協調合作
*英語口語和書面表達能力佳
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!
10/23
虹堡科技股份有限公司電腦及其週邊設備製造業
1. 材料承認書管理
2. 生產發現到材料不良之異常處置
3. 進料品質檢驗，記錄之整理及存檔，並追蹤反鐀
4. 進料品質不良履歷之建立
5. 供應商進料品質週報
6. CKD出貨規格料號、數量、包裝之查核
7. 主管交辦事項
薪資將依個人學歷、經歷及專業能力做為核薪依據
10/16
新蓬萊食品股份有限公司其他食品製造業
1、現場環境巡檢與現場半成品、成品品質檢驗。
2、原物料與半成品進貨驗收。
3、微生物檢驗操作 (總生菌數、大腸桿菌、大腸桿菌群、仙人掌桿菌快篩檢驗)。
4、ISO22000相關程序書、QC工程圖、HACCP計畫書修改與撰寫。
5、食品法規更新與歸檔。
6、支援品管研發部專案執行。
7、儀器校正。
8、病媒防治執行與資料統計、分析。
9、協助主管執行進行年度內部稽核。
10、其他主管交辦事項。
11、以上實際工作依個人經歷與專長調整、分配。
*應具證書：HACCP 60A
*此職缺需核備工廠衛生管理人員。
10/17
訊聯細胞智藥股份有限公司其他醫療保健服務業
醫藥/醫療器材/化妝品領域都是我們正在找尋的人才喔 ~
1.負責彙總、解讀藥物註冊法規、技術要求(包含但不限於TFDA、FDA法規、ICH指南)，並為公司研發提供合規指導和風險管理；
2.準備原始IND、修改和補充，包括與其他部門對接以獲得必要的組件和草稿報告和敘述組件
3.了解藥品的生命週期和基本的GMP工作流程
4.積極參與監管報送流程及參與產品開發週期的風險評估
5.跟進公司在研專案分配與協調，跟進註冊專案進度，及時發現和處理註冊專案進程中的問題，確保完成註冊任務;
6.協調和處理註冊評審過程中的相關問題；
7.及時掌握藥品註冊政策的變化情況，對研發人員進行培訓和管理。
1. To prepare timely original IND, amendments, and supplements, including interfacing with other departments to obtain the necessary components and drafts reports and narrative components
2. Understanding of the lifecycle of drug products and basic GMP workflow
3. Actively involved in the regulatory submission process
4. Involve in the risk assessment during product development cycle