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公司介紹
產業描述
藥品製造業
電話
暫不提供
員工人數
300人
地址
苗栗縣竹南鎮竹南科學園區科東三路1號 (新竹科學園區)
公司簡介
保瑞集團擁有國際化的領導團隊、專業的藥業行銷與經銷經驗，以及具備世界級製藥技術的實力。成立至今，深耕台灣，計畫性地發展研發、代工生產、經銷代理等各大事業主軸，一步一腳印的成長至今日的跨國集團規模。我們在台灣和加拿大擁有7座符合國際認證的生產廠房，具備最先進的儀器設備，提供自藥品研發、生產製造、檢驗測試、申請核准、認證登記到包裝運送等全面性客製化的委託開發暨生產製造服務。 目前代工與自有生產藥品已行銷全球超過100個國家，包含美洲、歐洲、東南亞及中東等國，成為台灣醫藥製劑登陸各國市場的重要橋樑。 “Contributing to Better Health All Over the World” 是每個保瑞人的使命，未來的每一步，保瑞集團也將秉持一貫的企業理念，堅持嚴格的品質標準，提供高品質的產品與高效率的服務，成為全球首屈一指的CDMO藥廠，讓全世界看到保瑞做的藥，並邁向營收與獲利的永續成長。 Bora STAR是保瑞集團的企業核心精神： ☆ Solve problems first 對事不對人 ☆ To do the right thing 做對的事而非容易的事 ☆ Always be proactive 自動自發 ☆ Respect everyone 互相尊重 益邦製藥(股)公司座落於竹南科學園區，佔地超過 20 萬平方英尺，前身為美國上市公司 Impax Laboratories,Inc.(NASDAQ: IPXL)百分百在台投資之子公司。其生產廠房已通過美國食品藥物管理局（FDA）查廠，英國MHRA 及台灣TFDA查廠，廠房年產能可達20億顆錠劑及膠囊，目前係全台唯一全廠產品外銷美國市場之專業製藥公司。目前員工人數近 300 位，80%員工為大學以上學歷，擁有碩博士學位者達30%，其中不乏國內外知名學府生化製藥學所培養出來的專業人才。
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公司環境照片(8張)
福利制度
法定項目
其他福利
益邦製藥提供與美國製藥大廠一致規格的辦公與製造工作環境，從設計到建造皆聘請國內外專業團隊精心規劃，以結合機能性的空間動線，充份詮釋益邦製藥堅守符合世界級品質要求之經營策略。 *具競爭力的薪資水準 *每年依據績效/市場薪資調查結果調薪 *優於勞基法的休假制度 *免費提供用餐、現磨咖啡機及飲料機 *免費員工停車位 *員工/眷屬團保 *年度員工健檢 *年度員工旅遊 *三節禮金禮卷 *多元化社團活動 *員購優惠
公司發展歷程
2024.07
保瑞藥業榮獲《HR Asia》2024年「亞洲最佳企業雇主」獎Best Companies to Work for 、最佳雇主關懷獎MostCaringCompanyAwards
2023.12
保瑞集團榮獲“2023年度最傑出企業獎”！ 總統蔡英文特地親自接見、並再次肯定了保瑞在全球委託開發代工製造CDMO領域的卓越成就。
2019.06
保瑞藥業榮獲《HR Asia》雜誌2019年「亞洲最佳企業雇主」獎（Best Companies To WorkFor）
2018.12
保瑞藥業榮獲2018年第八屆「台灣併購金鑫獎」最佳創意併購獎
2017.12
益邦製藥加入保瑞藥業集團(Bora Pharmaceuticals)。
2014.04
完成二期廠房擴建工程
2007.10
益邦製藥在竹南科學園區成立第一期廠房
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工作機會
9/23
We are seeking a proactive and detail-oriented Customer Operations (Senior) Planer/Supervisor/Associate Manager to serve as the key liaison between our internal teams and external clients. This role is responsible for managing customer demand, coordinating order fulfillment, and ensuring timely delivery and service execution. The ideal candidate will have strong communication skills, SAP experience, and a solid understanding of manufacturing and logistics processes.
________________________________________
Key Responsibilities
•Customer Demand & Order Management
•Manage customer demand planning and maintain sales orders in SAP.
•Allocate production plans based on shipping schedules and batch sizes.
•Track product release timelines to ensure on-time delivery.
•Cross-Functional Coordination
•Collaborate with Manufacturing, QA, and QC teams to monitor execution status and adjust schedules as needed.
•Coordinate shipping release activities and ensure compliance with quality and regulatory requirements.
•Shipping & Documentation
•Create delivery notes and plan shipping schedules.
•Support logistics arrangements and documentation preparation.
•Service Quotation & Billing
•Provide service quotations to clients and follow up on confirmation and billing.
•Coordinate with Finance for invoicing and payment tracking.
•Customer-Supplied Material Management
•Monitor and manage customer-supplied materials, including inbound tracking and release coordination.
•Reporting & Analysis
•Prepare revenue projection reports and shipping performance summaries.
•Generate routine operational reports (e.g., weekly shipping status, order fulfillment rate, material availability).
•Ad-Hoc Assignments
•Execute tasks assigned by management, including special projects, client escalations, and process improvement initiatives.
9/23
•Support the project and validation manager in preparing Project Execution Plan and update site Validation Master Plan.
•Prepare and implement qualification protocols (IQ, OQ, PQ) used in the production of pharmaceutical products. Where possible, as assigned by the project manager to manage projects related to movement and modification of the manufacturing equipment.
•Implement qualification activities, validation protocols, and calibrations in accordance with the needs of the production schedules.
•Conduct periodic review of URS/FRS/DDS or DQ to meet the latest regulatory requirements or guidelines from ICH or FDA CFR’s.
•Assist in the development and revision of Validation SOPs.
•Assist in troubleshooting of equipment and process deviations.
•Provide timely and accurate information of validation parameters established for equipment and facilities.
•Acts as liaison with Engineering, Technical Service, and Quality Assurance.
•Assist engineers/technicians in the development and completion of validation studies and protocols as needed.
•Other tasks as assigned by the company.
9/23
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:07:00~15:30,中班:15:00~23:30,夜班:23:00~07:30，目前以早中為主，夜班會依個人需求評估
7.週休二日，休國定假日
9.Team Award獎金$2,000/月
10.輪班津貼另計/加班費另計/提供免費工作餐/有停車場
11.有提供至後龍的交通車
※有固體製劑經驗者，薪資另議。
9/25
•Drive talent management processes including workforce planning, onboarding of new hires performance management and talent development program.
•Support employee relations by addressing employee concerns, conducting investigations, and facilitating conflict resolution.
•Collaborate with HR Centers of Excellence (e.g., Learning & Development, Talent Acquisition, Compensation, Payroll) to deliver integrated HR solutions.
•Supporting change management initiatives and organizational development efforts.
•Administer employee performance review programs, providing guidance to managers and employees.
•Provide guidance and support on employee relations issues, conflict resolution, and disciplinary actions.
•Ensure compliance with labor laws and company policies within assigned business units.
•Maintain and update HR records, employee files, and HRIS systems.
•Assist with benefits administration and open enrollment processes.
•Coordinate training and development programs to support employee growth.
•Collaborate with management to develop and implement HR policies and procedures.
•Support employee attendance tracking.
•Participate in HR projects and initiatives as needed to improve HR service delivery.
9/23
1.組裝/拆解/清潔 製程設備：例如數粒機、鎖蓋機及說明書機。
2.依據規劃排程執行製造生產。
3.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。
4.執行主管交付之其他任務。
5.需配合三班制輪班，目前以早班中班為主。(輪班津貼、加班費另計)
6.提供免費工作餐，B1設有停車場。
9/23
*Ensure change control system is robust and routed in a timely manner.
Plan, execute and follow up on internal audit program to assure conformance with *Current Good Manufacturing Practices (cGMPs).
*Coordinate, accompany and follow up Regulatory Authorities GMP inspection, PAI for new product and Third Party Audits by Customers.
*Perform supplier qualification and maintenance
*Manage the regulatory updates, implementation and compliance related procedures.
*Participate, facilitate and review investigations of deviation, laboratory investigations and product complaint. Propose, review and implement corrective and preventive actions to address the identified root cause(s).
*Collect, compile, review annual product review document. Maintain and provide statistics support of QCAL.
*Support cleaning validation tasks.
*Support and execute QIP fo for site innovation, improvement and enhancement of regulatory requirement
*Other tasks as assigned by the company.
9/23
1. 機器維修能力(故障分析與排除)
2. 機器保養系統操作維護改善。
3. 部門工作計畫及相關專案之執行。
4. 自動化系統維護及提升系統效能 。
白班，週休，需輪值中班(15:00-24:00)，通常1-2個月輪值一周，輪班津貼另計
9/23
1. 生產製造相關文件(批次紀錄/表單/紀錄本)審核。
2. 生產製造參數收集(基本Excel操作)
3. 生產製造相關耗材的管控、開單及領用。
4. 現場人員GMP文件訓練進度追蹤。
5. 執行主管交付之其他任務。
6. 現行是白班工作，根據需要配合輪班(早班:07:00~15:30,中班:15:00~23:30）
9/25
Job Summary:
1.Provide QA oversight CDMO Projects and Site compliance activities with quality oversight for commercial batches.
2.Achieve QA department goals and company objectives.
Job Duties and Responsibilities:
1.CDMO Projects - Quality oversight on quality activities including review and approve documentation, change controls for trial/submission batches.
2.Supplier Management - Manages Supplier Qualification, Audit program and Approved Supplier List
3.Audit Management - Manages internal and external audit activities, reviews and supports site audit readiness strategy, oversees preparedness for audits from agency (FDA, TFDA), or external audits from the sponsors/customers, support regulatory actions follow-ups on audit non-conformance resolutions and CAPA follow-ups.
4.To provide oversight for site self-inspection programs and implement continuous improvement initiatives.
5.Management of Quality Assurance Agreements (QAAs) – Establish and ensure current QAAs is up-to-date to support CDMO operations.
6.Site Score cards Management – Coordinate and report site quality metrics and organize quality councils
7.Oversight on annual CGMPs refresher training, coordinate periodic GEMBA walks and support site QIP programs to ensure site compliant to current FDA CFRs, TFDA regulations and customers requirement per Quality Assurance Agreements established for CDMO activities
8.Ensure personnel training/ qualification and curriculum are aligned to job roles and responsibilities
9.Others: Any additional assignment requested by Supervisor.
9/25
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
9/25
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。
9/25
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。
9/25
• 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
9/25
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.
9/10
1.支援系統(鍋爐、純水處理、廢水處理、CIP系統、給排水系統等)例行保養、異常修繕及庶務性保修作業。
2.支援系統(FMS/PMS/空調系統/電力系統/壓縮空氣系統/消防系統等) 保修作業偕同。
3.中央監控系統、製程生產設備、空調電力系統、空壓系統、消防….等保修作業偕同。
4.全廠儀錶年度校驗及確效驗證作業支援。
5.設備SOP撰寫、設備維護履歷建置，以及數據收集分析。
9/10
The Engineering Supervisor is responsible for managing utility operations, leading the Engineering and Maintenance team, ensuring instrument calibration, performing preventive maintenance, and overseeing equipment qualification activities in a pharmaceutical manufacturing facility. This role ensures compliance with GMP standards, regulatory requirements, and internal SOPs while supporting continuous improvement initiatives.
9/24
1.工安及環保管理業務籌劃、推行及改進建議事項。
2.工安及環境保護許可管理。
3.規劃及督導職業安全衛生及環境保護設施之點檢與檢察。
4.有害作業環境之採樣策略規劃及評估並結合特殊健檢。
5.機械設備法規鑑別及查核。
6.工安、環保及其他相關法規鑑別及查核。
7.公部門單位訪查對應。
8.其他安全及衛生交辦事項。
9.SOP文件撰寫、改版更新、中央監控系統操作及表格填寫。
10.其他主管交辦事項。
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