『中壢廠』QA Associate Manager/Manager(Compliance/Supplier Mgt)
(保瑞藥業)Bora Pharmaceutical Laboratories Inc._益邦製藥股份有限公司
本網頁由成功大學生涯發展組與104人力銀行共同經營創建，源於南區就業博覽會徵才企業職缺，同意在此提供更多且適職的工作機會予求職者
(保瑞藥業)Bora Pharmaceutical Laboratories Inc._益邦製藥股份有限公司
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。
工作內容
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.
條件要求
英文 -- 聽 /精通、說 /精通、讀 /精通、寫 /精通
Requirements: 1.Good written fluency for technical reporting in Chinese and English 2.Confident for spoken fluency in Mandarin and English 3.Minimum 5 years work experience in a supervisory role within QA Compliance functions in a manufacturing operations/CDMOs industry for pharmaceutical and/or medical devices 4.Good knowledge and experience on Quality Compliance functions 5.Good knowledge on CGMP principles and use of investigation tools for root cause analysis 6.Minimum B.Sc. in Chemistry, Bio Sciences/Life Sciences, Pharmacy or Chemical Engineering 7.Relevant training on GMP and ISO standards 8.Training or certification as Auditor/ Lead Auditor for Pharmaceutical Quality Management Systems or ISO 13485 standard 9.Maintain positive work attitude/ethics and integrity 10.Possess critical thinking and continuous improvement mindset
公司環境照片(8張)
福利制度
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