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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
10/30
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
10/30
•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.
10/29
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。
10/30
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。
10/30
Ensure the change control system is robust and processed in a timely manner.
Plan, execute, and follow up on the internal audit program to ensure conformance with current Good Manufacturing Practices (cGMPs).
Coordinate, accompany, and follow up on GMP inspections, PAIs for new products, and third-party audits conducted by customers or regulatory authorities.
Perform supplier qualification and ongoing maintenance.
Manage regulatory updates, implementation, and compliance-related procedures.
Participate in, facilitate, and review investigations of deviations, laboratory incidents, and product complaints. Propose, review, and implement corrective and preventive actions (CAPA) to address identified root causes.
Collect, compile, and review annual product review documents. Maintain and provide statistical support for QCAL.
Support cleaning validation activities.
Support and execute QIPs for site innovation, improvement, and enhancement in accordance with regulatory requirements.
Perform other tasks as assigned by the company.
10/27
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.
10/27
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
10/27
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。
10/27
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。
10/27
• 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
10/27
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.
10/30
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。
10/30
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.
10/30
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。
10/29
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.
10/30
1.Perform process validation in accordance with company and regulatory requirements.
2.Prepare and revise production Master Batch Record for process validation and commercial.
3.Execute manufacturing process.
4.Prepare data summary and reports.
5.Other duties as assigned, such as shipping study, bulk hold study, and packaging validation.
10/29
1、Create and/or revise controlled documents, and ensure relevant trainings are completed in a timely manner through a robust change control process.
2、Plan, execute and follow up on internal audit and external audit programs to assure conformance with cGMPs.
3、Coordinate, accompany, and follow up Regulatory Authorities GMP inspection, PAI, and Client audit. Ensure procedure compliance by managing regulatory updates and implementation.
4、Ensure compliance with CSV master plan and procedures, relevant regulatory guidance, customer requirements for the implementation of computer system.
5、Ensure Bora GDP procedures are established, followed, and executed appropriately in compliance with Current Good Distribution Practices (cGDPs)
6、Participate, facilitate, and manage samples for analysis; ensuring correct and timely sample collection and delivery.
7、Collect, compile, and review annual product review document.
8、Other assigned tasks
10/29
1、Create and/or revise controlled documents, and ensure relevant trainings are completed in a timely manner through a robust change control process.
2、Plan, execute and follow up on internal audit and external audit programs to assure conformance with cGMPs.
3、Coordinate, accompany, and follow up Regulatory Authorities GMP inspection, PAI, and Client audit. Ensure procedure compliance by managing regulatory updates and implementation.
4、Ensure compliance with CSV master plan and procedures, relevant regulatory guidance, customer requirements for the implementation of computer system.
5、Ensure Bora GDP procedures are established, followed, and executed appropriately in compliance with Current Good Distribution Practices (cGDPs)
6、Participate, facilitate, and review investigations of deviation, laboratory investigations and product complaint and relevant CAPAs to address the identified root cause(s).
7、Collect, compile, and review annual product review document.
8、Other assigned tasks
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