(保瑞藥業)Bora Pharmaceutical Laboratories Inc._益邦製藥股份有限公司
『桃園蘆竹廠』 QC Supervisor
10/7 更新
Array
全職
高級
英文 條件要求
0 ~ 5 應徵者

職務概況

待遇面議
(經常性薪資達 4 萬元或以上)
桃園市蘆竹區

條件要求

語文條件
英文
聽/精通、說/精通、讀/精通、寫/精通
工作經歷
3年以上

職務描述

The Supervisor of Quality Control is responsible for laboratory relevant documents preparation, analytical data review, Lab work arrangement, and schedule and monitor the calibration and preventive maintenance activities of Lab equipment. Besides, also mainly engages with lab investigation, problem solving activities,
• Monitors all GMP activities related to QC lab operations by following the relevant SOPs.
• Prepares and reviews specifications for raw materials, in-process materials and finished products.
• Reviews Lab analytical data, notebooks and executed Specification and Quality Assurance Report.
• Organizes and plans own daily workload within the daily, weekly or monthly priority plan.
• Conducts and leads Lab investigation and reviews reports.
• Responsible for issuance, control and archive of Lab notebooks and logbooks.
• Prepares and reviews relevant SOPs, associated with adequate training materials
• Provides training to analysts. Trains laboratory staff for all testing and equipment operation in the laboratory.
• Schedules, monitors and reviews all calibration and preventive maintenance activities and reports of Lab equipment.
• Ensures that all reagents and volumetric solutions are made up and standardize according to SOP procedures.
• Alerts Laboratory Managers verbally in the event of any result not meeting specifications and any atypical trend of historical test results in timely manners.
• Ensures that the expiry dates of all analytical reagents developed in-house are recorded on container or document.
• Ensures that the handling including disposition of all dangerous materials, such as arsenic, cyanide, and concentrated acids, in accordance with standard safety practices.
• Ensures that the recording of 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.
• Records KPI (Key Performance Indicators) elements and implements adequate actions to react and maintain continuous improvements.
• Completes specific delegated tasks or assigned duties by the agreed completion date.
• Attends weekly laboratory meetings or delegated meetings.
• Other duties as assigned by the supervisors or company.
需求人數
1~1人
學歷要求
大學(學院)以上
科系要求
化學相關、藥學相關、食品科學相關
上班時段
08:00-17:00
休假制度
週休二日
職務類別
QA / QC Engineer
ISO / Quality Assurance Staff
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。
0 ~ 5 應徵者