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.
职能类别: 药品生产/质量管理 生物工程/生物制药
联系方式
上班地址:外高桥保税区
部门信息
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