• 3-4年经验
  • 本科
  • 招2人
  • 02-07 发布
  • 五险一金
  • 免费班车
  • 员工旅游
  • 餐饮补贴
  • 专业培训
  • 年终奖金
  • 股票期权
  • 弹性工作
  • 定期体检

职位描述

工作描述JOB DESCRIPTION 2.1 Create and maintain specification, analytical methods, SOPs and training materials. 2.2 Responsible for sampling/sample retention management of raw materials. 2.3 Create the work plan of raw materials testing including physical/chemical tests and follow up the plan implementation status to support related production. 2.4 Process analytical data in workstation for acceptability of calibration curve, control values and chromatograms. Responsible for investigation of incident reports and OOS/OOT results, management of CAPAs and Change Control program within QC\QA team. 2.5 Ensure the requirements for GMP, SOP or regulatory and EHS are met within the QC areas. 2.6 Assist director in lab related activities, which include coordinating with sample manager, instrument scheduling, report writer, etc., and communicate with other functions for test related issues, provide related supports to other functions. 2.7 Improve and maintain compliance system within the QC areas. Participate internal and external GMP audits if necessary. 人员资质 PERSONAL QUALIFICATION 3.1 Must be trained in or have experience with the requirements of GMP regulations. 3.2 Be familiar with pipettes, mixer, centrifuges and other equipment for sample treatment. 3.3 MS degree in a science discipline with experience or training in Analytical or Biological Sciences. 3.4 Must be experienced in analytical techniques, UV spectrophotometer and HPLC, etc. 3.5 Be skillful at reading, understanding and writing English documentation. 职能类别: 生物工程/生物制药 关键字: QC 原辅料 检测 抽样 主管 分析

联系方式

上海市外高桥保税区富特中路288号

公司信息

药明生物(WuXi Biologics)是香港上市公司(代码:2269),我们是全球领先的开放式、一体化生物制药能力和技术平台,旗下包括无锡药明康德生物技术股份有限公司、上海药明生物技术有限公司、苏州药明康德检测检验有限责任公司,并在美国和英国设有子公司。公司为全球生物制药公司和生物技术公司提供全方位的端到端研发服务,帮助任何人、任何公司发现、开发及生产生物药,实现从概念到商业化生产的全过程,加速全球生物药研发进程,降低研发成本,造福病患。目前,公司规模达到2300多人,有200多位拥有海外高等学位和工作经验的海归科学家,拥有丰富的欧美市场抗体开发、生产、质量控制、临床前研究和注册的经验,打造了世界一流的生物药研究、开发及生产团队。 更多信息,请登录公司官网:http://www.wuxibiologics.com.cn/

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