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)
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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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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工作機會列表
4/21
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.
4/21
1. Perform laboratory analysis such as Potency Assay, Water Content, Impurities, BD/TD/PSD.
2. Conduct quantitative analysis using Balance, pH/Conductivity meter, Karl Fischer Titrator, Autotitration, GC, HPLC, UPLC/MS, IC, CE and TOC instrument.
3. Maintain the analytic instrument system performance with basic troubleshooting skill per lab preventive maintenance/calibration program.
4. Assist in standard operation procedure (SOP), test method, specification revision and change control documentation work.
5. Perform the raw data/audit trail/logbook review
6.Assist in CMO related activities such as method verification and method transfer
4/21
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）。
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。
4/21
Key responsibilities include the following, but are not limited to:
1. Generate Quotations:
- Coordinate CDA/agreements execution between Bora/Client
- Coordinate internally to gather information required for quotation
- Put together a quotation for Management approval
- Provide quotations/project proposal to Client and follow-ups
2. Client Communication Management
- Serves as a central hub of internal/external communications with existing clients/third parties for project and product changes
- Serves as a central hub of internal/external communications with potential new clients /third parties to provide proposal to meet their needs and to enhance company business opportunities
- Confirm efficient and accurate information exchange between parties
- Schedule and arrange project meetings and task assignments, communicate expectations and changes to project team members, record meeting minutes/critical decisions and track completion of project deliverables to ensure quality and integrity of all project-related products
3. Project Planning:
- Establishes project charter and plan to define project scope and timeline
- Assign tasks and perform follow-ups to ensure timely deliverables
- Identify potential issues and risks, and solutions.
4. Project Execution and Delivery:
- Drive project activity execution to meet goals/objectives and the agreed plan without compromising project deliverables or relationships
- Propose solutions on a variety of issues with low to moderate complexity and changes
- Gather information, and apply analytical and interpretation skills to tackle problems of diverse scopes
- Help resolve project conflicts, identify resource requirements and align project teams on common project scopes and objectives
- Track and maintain regular and ad hoc reports to gauge progress and performance status
- Complete work in accordance with PMO’s best practices and methodologies
- Assist in managing multi-cross functional team works to meet successful deliverables/outcomes
- Ensure compliance with up-to-date regulatory guidance
- Leverage robust project management skills and co-work with project managers to drive key decisions and milestones according to the endorsed plans, timelines, costs, and quality parameters
5. Perform other PMO-related duties/tasks as assigned by Management
4/21
1. 執行製程管制試驗、IPC取樣、製程檢驗。
2. 各製程階段半成品、成品及安定性取樣。
3. 協助執行現場環境監控與設備清潔確效抽樣。
4. 協助GMP異常的調查、文件整理、歸檔及主管交辦事務處理。
※輪班津貼另計，現僅有早班/中班（早班:07:00~15:30,中班:15:00~23:30）。
4/21
1.編制和管理財務報表及年度預算，提供經營管理分析。
2. 提供經營管理所需的資訊分析，以協助決策過程。
3. 申請租稅優惠及免稅案件，確保符合相關法規要求。
4. 協助集團經營管理分析團隊其他成員，確保團隊目標的達成。
5. 完成其他主管交辦的事項
工作地點: 台北/中壢/竹南
4/21
-Fully support SCM planner material requirement plan, and ensure the availability of material supply.
-Implement a cost/quality improvement program through the identification of value-added opportunities.
-Ensuring that all procured items meet the required quality standards and specifications.
-Tracking and maintaining the status of orders, and reporting any delivery issues to ensure the delivery was met.
-Maintain vendor, material master data, and materials pricing in ERP.
-Track and report supplier performance, and perform the annual vendor evaluation.
-Evaluate and negotiate contracts with vendors.
-Manage returns for damaged and incorrectly shipped materials.
-Material Quality Complaint.
-Prepares reports and price analysis related to area of responsibility as directed.
4/21
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 。
其他:需輪值中班(15:00-24:00)，通常一個月輪值一周，輪班津貼另計
薪水視履歷/經驗綜合考量
4/21
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。
4/16
•Responsible for creation and maintenance of work orders in the SAP system.
•Allocates materials for work orders and provides shop packets to QA and Warehouse to support batch record issuance and material staging.
•Coordinates with Manufacturing, QA and QC to determine the status of execution of the schedule, adjusting and reporting on changes as required.
•Coordinates with other site planner for STO.
•Coordinates with procurement team, and provide related material rolling demand forecast to vendor.
•Coordinates with bonding specialist to reduce import cost.
•Ensure an uninterrupted supply of raw materials, packaging and supplies for manufacturing under cGMP standards and requirements.
•Support the project material requirement planning.
•Monitor inventory MOH and ordering volume consider cost, shelf life, lead time, analytical cost etc. to come out better MOQ.
•Maintains master data such as product masters, bills of material in the SAP system.
4/15
•Lead project formulation and process development independently
•Work independently in setting up/cleaning, operating, troubleshooting and processing batches on lab and manufacturing equipment
•Analyze patent application, conduct/plan pre-formulation studies, excipients selections, identify technical problems and initiate stability studies
•Characterization of the physical-mechanical properties of in-process or final dosage forms
•Prepare project progress reports, weekly meeting, manufacturing batch records and submission documents
•Able to communicate with other departments to schedule and perform necessary task
•Complete all SOP and GMP training and follow good lab and GMP practice as necessary
•Other tasks as assigned by the company.
4/21
1 .執行例行微生物分析，包含原物料、RD分析方法確效、中間體、成品。
2. 執行非例行工作，包含分析方法轉移、確效、驗證、計劃書編訂、品質事件調查。
3. 共同維護實驗室運作。
4. 執行水質取樣，包含自來水、純水與注射用水。
5. 協助執行環境監控與中間體取樣。
6. 針對品質事件，需辨識問題、協助收集數據、繪製事件真相與提出有效的結論。
7. 遵循公司與部門制定之環境安全衛生規範，以及公司政策。
8. 維護儀器及實驗室環境，已符合cGMP之要求。
9. 其他主管交辦事項。
4/21
1. CDMO專案：
(1) 參與CDMO客戶會議討論，並配合討論內容修改製程設計。
(2) CDMO專案技術轉移相關文件(protocol, report, and master batch records)之制定、教育訓練及執行。
(3) CDMO專案之預試驗、試製及GMP生產批 (Lab-scale & Submission/Commercial batch scale)，並執行廠內教育訓練。
(4) 料號管理、原物料請購及庫存管理。
(5) 專案進度追蹤及其他因異動而進行之即時性調整。
2. 製程相關驗證確效作業：
(1) 製程設備之性能驗證計畫書及報告書之制訂及審閱、協調相關部門依計畫書內容執行及分析結果，並於執行前安排教育訓練。
(2) 確效主計畫書之維護及更新。
(3) 製程確效、清潔確效、無菌製程模擬確效 (Aseptic process simulation; media fill)及其他。
(4) 驗證確效排程及進度管理。
3. 市售產品trouble shooting：
(1) 市售產品發生異常事件時，協助品質部門執行相關技術性之調查。
(2) 市售產品安定性數據發生異常時，經調查後依規定進行處方或製程優化。
4. 部門行政事務：
(1) 請購清冊及固資清冊管理。
(2) 主管交辦事項。
4/16
1. CDMO專案：
(1) 參與CDMO客戶會議討論，並配合討論內容修改製程設計。
(2) CDMO專案技術轉移相關文件(protocol, report, and master batch records)之制定、教育訓練及執行。
(3) CDMO專案之預試驗、試製及GMP生產批 (Lab-scale & Submission/Commercial batch scale)，並執行廠內教育訓練。
(4) 料號管理、原物料請購及庫存管理。
(5) 專案進度追蹤及其他因異動而進行之即時性調整。
2. 製程相關驗證確效作業：
(1) 製程設備之性能驗證計畫書及報告書之制訂及審閱、協調相關部門依計畫書內容執行及分析結果，並於執行前安排教育訓練。
(2) 確效主計畫書之維護及更新。
(3) 製程確效、清潔確效、無菌製程模擬確效 (Aseptic process simulation; media fill)及其他。
(4) 驗證確效排程及進度管理。
3. 市售產品trouble shooting：
(1) 市售產品發生異常事件時，協助品質部門執行相關技術性之調查。
(2) 市售產品安定性數據發生異常時，經調查後依規定進行處方或製程優化。
4. 部門行政事務：
(1) 請購清冊及固資清冊管理。
(2) 主管交辦事項。
4/16
The Specialist is mainly responsible for laboratory experiments executions, Lab equipment calibrations and preventive maintenance, preparation and/or revision QC relevant SOPs/SQARs/reports, lab control activities and compendia update related activities. Be able to host project activity or subject that may enhance the lab operations in quality and efficiency.
• Performs QC Lab activities by following relevant present SOPs.
• Prepares and revises QC relevant SOPs, associated training materials.
• Prepares reagents that are to be used for analysis. Standardizes volumetric solutions by using standard written methods at specified intervals.
• Analyses products, raw materials, packaging materials and stability samples according to laid down procedures in testing methods.
• Records analytical data and results in notebooks, logbooks, Specification and Quality Assurance Report and laboratory analysis forms accurately. Records results in a trending monitor perspective.
• Performs calibration and preventive maintenance activities of Lab equipment, in accordance with set methods and procedures.
• Validate/Verify new analytical method for the characterization and quality control of active pharmaceutical ingredients, intermediates, excipients and drug products.
• Perform the analytical testing for technical transfer projects or any requirement.
• Reports malfunctioning equipment to Laboratory Supervisors or deputies for repair.
• Alerts Laboratory Supervisors or deputies verbally in the event of any result not meeting specification or of any questionable results generated.
• Ensures adequate stocking of Laboratory reagents and consumables, through monitoring re-order levels and timely notification to Laboratory Supervisors or deputies.
• Records expiry dates of analytical reagents developed in-house by noting the expiry date on container or document.
• Handles and disposes dangerous materials, such as arsenic, cyanide, and concentrated acids, in accordance with standard safety practices.
• Records regulated toxic controlled chemicals usage and disposition in accordance with standard predetermined procedures.
• Maintains neatness of laboratory that following the concept of 6S – Sort, Set in order, Shine, Standardize, Sustain, and Safety.
• Supports investigative testing and investigation activities.
• Supports the compendia update and regarding assessment report preparation activities.
• Perform in a continuous improvement attitude to meet the predetermined KPI.
• Follows the training program schedule to complete the directed training courses.
• Completes delegated tasks by the agreed completion date and treats as commitment.
• Attends weekly laboratory meetings or delegated meetings.
• Prepares and revises test methods.
• Prepare and revise relevant technical reports.
• Other duties as assigned by supervisors or company
4/16
-子公司(蘆竹廠)
1. 負責眼藥水、眼藥膏之調配、生產及產線維護。
2. 完成生產作業相關品質需求。
3. 機動性協助(包裝作業、包材領料)。
4. 其它主管交辦事項。
4/16
依身心障礙者權益保障法規定，維護其就業權益、善盡社會責任，本職務為專為身心障礙人士開設職缺，無身障手冊者請勿投遞。
1. 維護辦公室環境清潔。
2. 協助產線衣物洗衣折衣。
3. 結帳:總務請購附上請款相應的單據。
4. 領取每日郵件，能協助外出寄信寄包裹者佳。
5. 訪客倒水泡茶，大型活動拜拜普渡協助相關事宜
6. 清潔用品消耗材、雜用品代收貨品並通知需求單位領取。
7. 主管交辦事項。
4/21
To perform independently one or a limited number of specific functions within QA, the specific QA function could be:
1. Regulatory/registration documents review and preparation to meet local regulatory requirement or exported affiliate’s requirement.
2. Provide the assessment in site change control with regulatory point of view and coordinate with affiliates for site change control execution.
3. Coach and provide regulatory information and support.
4. Coordinate with affiliates for maintenances the most updated product licenses.
5. Be a site coordinator to handle the new/revised artworks approval process.
6. Package components management.
7. Document management
8. Change control management
9. Perform internal audits for assign topics.
10. Handle Site Quality Review Team Meeting
11. Others: Assign as requested by supervisor.
4/21
1. 遵守GMP流程-執行中央空調系統/廠務系統日常操作巡檢紀錄、維護、異常分析與改善（包括系統備份、警報處理）。
2. 遵守GMP流程-依矯正工單生產設備異常修繕工作
3. 廠區緊急狀況處置
4.執行主管交辦工作
4/21
QA調査合作，年度報告的調査/資料彙整,熟悉QA調査架構
1. Handle outsourcing activity including qualification/re-qualification from contract
manufacturing (CMO), contract packaging (CPO), contract laboratory (CTL) and review the related Quality Agreement (QAA)
2. Ensure the qualification/re-qualification from packaging components (CPO) on track.
3.Investigation handling for IR/ LIR/Complaint
4.Author for SOP revision
5.Perform trending and risk assessment report.
6.Support internal audit / external audit
7.Other : Assignment as requested by the management
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