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  • 招1人
  • 11-09 发布

职位描述

职位描述: KEY RESULT AREAS & JOB ACTIVITIES /TASKS1.Product Development – Launches, Submissions, and Clinical Test Supplies?In conjunction with Principal scientist, responsible for formulation and process development for new products aligned with the Global Franchise teams in support of the Asia Pacific region.?In conjunction with Principal scientist, responsible for technology transfer for new and/or existing products into and out of the region.?Play a major role in the scale-up and manufacture of demonstration/registration/validation batches. Monitors and assists with manufacture of clinical batches on an as needed basis.?In conjunction with Principal scientist, plans, executes and manages both routine and non-routine projects simultaneously with general criteria for results?Performs data collection and analysis, discuss conclusions regarding progress of work, and effectively communicates information to supervisor in the form of discussions and reports.?Authors’ protocols, reports, technology transfer protocols/reports and other technical documents (i.e. Master Formula, specifications) as part of the product development and technology transfer process. Author documents for regulatory submissions.?Establishes and monitors developmental stability programs to assess viability of dosage forms.?In conjunction with Principal Scientist, maintains effective, collaborative, and frequent interactions with US-based R&D groups to ensure harmonization in scientific and technical approaches.?Be an active contributor supporting Principal scientist through collaboration with Marketing, Regulatory, Medical, Technical Service, Supply Chain, Quality and the other cross-functional teams.2.Problem Solving?Solves complex problems using multiple problem-solving tools and techniques3.Innovation?Recommends innovative technologies to support core products, product improvements and/or line extensions.4.Compliance?Assures awareness and compliance with current and developing regulations with Boards of Health (i.e. SFDA,TGA, FDA etc), other regulatory agencies and with corporate policies.?Perform job responsibilities in compliance with cGMP, GLP and all other regulatory agency requirements, where applicable.BACKGROUND REQUIREMENTS1. Educational /Training?Major in Pharmacy, Pharmaceutics, Pharmaceutical Science or related field.2. Working Experiences?BS degree with a minimum of 5 years of relevant experience?MS degree with a minimum of 2 years of relevant experience?Ph.D. degree with no prior experience3. Communication?Good written and oral English skill?Good communication skillsCOMPETENCIES REQUIREMENTSTechnical Competency:?Ability to provide technical solutions to consumer product insights.?Demonstrated product development expertise.None Technical Competency:?Innovation?Understand consumers?Problem Solving?Project Management?Contributing to Team Success 职能类别: 生物工程/生物制药

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公司信息

辉瑞苏州药厂(惠氏制药有限公司)是世界五百强公司之一,成立于1991年7月,并于1994年11月正式投产。经过历次增资扩建,累计总投资额超过1.3亿美元,目前厂区面积43亩,共有员工近800人。 公司拥有按GMP标准建造的洁净厂房和世界先进水平的生产设备和技术。主要产品有钙补充剂、多种维生素、抗感冒咳嗽药、抗生素等多种处方药和非处方药,共计33种产品163个产品规格。除了满足国内市场的需求,部分产品已大量出口亚太地区以及拉丁美洲等12个国家和地区,成为集团亚太地区重要的供应基地之一。 公司采用全球最先进的质量管理制度和保证体系,其质量管理水平和记录在辉瑞全球生产制造集团中首屈一指。自1998年至今,公司通过了每一次国内外GMP审查并获得认证,为产品质量提供了强有力保障。为了进一步提升企业的质量标准,公司在内部实施 "持续规范运作"。持续规范运作的实施进一步提高了公司的GMP质量管理体系和运作水准,使公司的质量管理体系在同行业内处于领先地位,并多次受邀与国家、地方药监部门进行质量体系管理成果分享活动。 多年来公司一直延续着优异成绩,在内外部都取得了丰硕成果。截至到2015年,已经连续七年获得了总裁奖、连续六年获得***客户服务奖。2014年,公司更是战果辉煌,获得了辉瑞全球供应集团最高荣誉--总裁钻石奖,并成为辉瑞全球年度***工厂!公司曾获得过"江苏省质量信用等级A级企业"、"药品质量诚信建设示范企业"、"江苏省医药行业诚信企业"、"苏州市质量奖"、 "中国能效之星"等荣誉称号,并连续10多年获得苏州市、吴中区纳税大户称号,江苏省及苏州市各级领导多次来公司参观访问,他们都高度肯定了我们的成绩,以及对地方经济作出的杰出贡献。 在总部和苏州市及吴中区政府的大力支持下,辉瑞苏州新厂项目于2014年10月正式签署投资协议并于2015年10月正式动工,已于今年8月全面封顶,新厂位于苏州市吴中经济技术开发区吴淞江科技产业园,一期占地约70亩,投资约9600万美元,主要生产钙尔奇、善存系列产品,同时,还将在新厂建立新平台,并设置辉瑞健康药物部亚太区研发中心,为保证市场发展后劲注入源源不断的新动力。届时,辉瑞苏州将成为辉瑞全球最大的钙尔奇、善存生产基地。 建成后,一期片剂生产能力将达到38.5亿片/年,预留产能10亿片/年,预计2018年一季度投入商业化生产,项目还为未来发展留有二期、三期规划。新厂设计秉承了绿色环保、高效节能、可持续发展的理念,并将成为药品生产车间和综合楼LEED(美国绿色建筑协会能源和环境设计先锋奖)金级认证的行业先锋。 辉瑞苏州始终不断地坚持发展和自我改善,激励和吸引所有员工一起以辉瑞愿景为目标,力争做到快速、灵活、创新、以业务为中心和网络驱动,工厂还重点关注客户服务、成本效益、员工参与、改善内部流程等。我们已制定"成为具有创新精神的辉瑞全球业务伙伴并为客户创造最大价值"的2020战略目标。伴随新厂项目的建成,新的蓝图已经绘制,我们将继续努力,一步一个脚印地迈向下一个辉煌!

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