Group Leader/ Assistant Director
上海药明生物技术有限公司
- 公司性质:民营公司
- 公司行业:计算机软件
职位信息
- 发布日期:2019-06-28
- 工作地点:上海-浦东新区
- 招聘人数:1人
- 工作经验:1年经验
- 学历要求:本科
- 职位月薪:0.9-1.7万/月
- 职位类别:药品生产/质量管理 生物工程/生物制药
职位描述
Create and maintain specification, analytical methods, SOPs and training materials.
Responsible for sampling/sample retention management of raw materials.
Create the work plan of raw materials testing including physical/chemical tests and follow up the plan implementation status to support related production.
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.
Ensure the requirements for GMP, SOP or regulatory and EHS are met within the QC areas.
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.
Improve and maintain compliance system within the QC areas. Participate internal and external GMP audits if necessary.
Must be trained in or have experience with the requirements of GMP regulations.
Be familiar with pipettes, mixer, centrifuges and other equipment for sample treatment.
BS degree in a science discipline with experience or training in Analytical or Biological Sciences.
Must be experienced in analytical techniques, UV spectrophotometer and HPLC, etc.
Be skillful at reading, understanding and writing English documentation.
公司介绍
联系方式
- Email:Biologics@wuxiapptec.com
- 公司地址:荷丹路240号科创中心
- 电话:13482827135