Equipment Qualification / Senior Scientist 上海

月薪： 0.8-1万/月

该公司所有职位
  • 无工作经验
  • 本科
  • 招1人
  • 11-09 发布
  • 五险一金
  • 免费班车
  • 交通补贴
  • 年终奖金
  • 专业培训
  • 定期体检

职位描述

职位描述： Responsibilities：l Qualification, calibration and maintenance management: 1. Follow up the calibration plan and review the calibration documents. Follow up the maintenance plan and review the preventive maintenance documents. 2. Define validation, calibration and maintenance strategy, the necessary actions, the responsibilities and the documentation required in the validation procedure. Ensure validation compliance to cGMP, industry standards and regulatory expectations. 3. Organize the execution of preventive maintenance, calibration, and periodic review and requalification activities and communicate this with the related departments. l Change Control management: 1. Monthly monitoring of the progress of raised changes and follow up with action plans. 2. Able to write change controls, deviations and CAPAs in a logical and clear manner, and review these documents. 3. Yearly trend analysis of environmental monitoring results for the purified water system, nitrogen system, HVAC, compressed air system and production equipment. 4. Review of current equipment validation practices and propose changes to improve these practices, i.e. align them with US and EU standards. 5. Fulfill a consultant role in the field of equipment validation for QA and the production department.Requirements：1. Diploma or degree qualification preferred; B.S in Chemical, Mechanical, or Electrical Engineering (preferred) or Life Sciences degree. 2. Knowledge of cGMP requirements. 3. A minimum of three years of GMP experience in a biotech or sterile pharmaceutical manufacturing environment, or the equivalent, is desired. 4. Prior work in maintaining GMP biotechnology and/or sterile process equipment is required is desired. 5. Proficient in computer skills and MS Office applications. 6. Knowledge of process control systems (PLC, DCS and/or SCADA) is desired. 7. Knowledge of validation test instruments such as Kaye Validator is desired. 8. Excellent written and verbal communication skills. 9. Excellent written and spoken English communication skills. 职能类别： 生物工程/生物制药 关键字： 仪器验证，GMP

联系方式

上海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/

上海相关职位

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企业入驻日期： 2017-11-09

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