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
微信分享
联系方式
上班地址:上海市浦东新区哈雷路1090号
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