QC检测员(蛋白方向)
勃林格殷格翰生物药业有限公司ShanghaiUpdate time: May 10,2019
Job Description

Job Responsibilities
  • Responsible for arranging and carrying out testing for intermediates, bulk products and finished products, testing for stability samples. ensure to complete incoming analytical requests accurately and timely.
  • Participate into establish testing Specifications for product and relevant SOPs/Forms according to given instructions, ensure to comply with GMP, regulatory and BI requirements.
  • Supervise lab equipment qualification and maintenance, ensure to perform all tests smoothly.
  • Participate in analytical method transferring and validation.
  • Participate in OOS investigation.
  • Maintain the equipment, glassware, reagent etc. in productivity and cost saving status meanwhile complies with requirement from SFDA and company.
  • Follow related SOPs and regulations strictly in lab.
  • Fill in related documentation such as BAR, other logbook etc., timely to ensure the reliability of content as per requirement of SOPs.
  • Take part in actively in correction to the observations found in self-inspection.
  • Take part in the project management of QC.

Qualifications
  • Education/Degree Requirements: Bachelor degree and above.
  • Major: Biopharma/ Pharma/ Chemical related.
  • Language skills & proficiency: English skill.
  • At least 2 years’ experience in Quality Control in a bio pharmaceutical industry. Familiar with HPLC methods and general bio pharma tests applied in protein analysis; Familiar with the procedure to characterize protein’s purity, contaminant, oligo saccharides and peptide map, etc. Multinational pharmaceutical company experience is preferred.


职能类别: 质量管理/测试工程师(QA/QC工程师) 质量检验员/测试员

关键字: GMP CMO 外企 生物制药

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联系方式

上班地址:上海市浦东新区哈雷路1090号

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