QC Scientist 检测科学家(原辅料/包材)
复星凯特生物科技有限公司ShanghaiUpdate time: May 14,2019
Job Description
Accountbilities岗位描述:
  • Conduct related daily testing and test method development, such as endotoxin testing, TOC, Conductivity test,HPLC test 执行日常的相关测试和检测方法的开发,如细菌内毒素检测,总有机碳,电导率测试,HPLC 测试等。
  • Familiar with related test equipment, like PTS, pH, HPLC, UV, FTIR, HPLC 熟悉相应的测试仪器设备,如PTS、pH计、紫外、红外、气相色谱等。
  • Prepare test reports to support raw material/ product/ plant facility and other related material release. 准备支持原料、产品、厂房设施以及其他相关物料放行的相关报告。
  • Responsible for out test of raw material, package material 负责原辅料包材相关的外部测试。
  • Follow new project and strategy, develop the new analysis methods and technology. 结合公司项目从事新的检测方法和技术的开发工作。
  • Support to conduct cleanroom routine environmental monitoring. 协助执行洁净区域的日常环境监测。
  • All related lab activities must meet regulation requirements, like GMP, GLP. 所有相关的实验室行为必须符合相关法规要求,如GMP,GLP 。
  • Draft all QC related SOPs, including test SOP, management SOP, and update these SOPs basing on the validation results or trend assay results or regulation. 编写所有QC 相关的SOP,包括测试SOP,管理SOP,并根据验证结果或者趋势分析结果或法规及时更新相关SOP 。
  • Order and maintain the consumables and reagents used in QC testing. 采购并管理测试所需的试剂耗材。
  • Operate QC equipment, cooperate with relevant departments to conduct the equipment calibration and maintenance timely. 使用QC相关仪器,和相关部门合作及时实施仪器的校验和维护。
  • Cooperate with other department to conduct related validations, draft protocols, perform the procedures, analyze and report the results. Participate in related deviation/OOS investigations. Timely review the abnormal cases. 和其他部门合作进行相关的验证工作,编制方案,实施检测,分析并汇报结果。参与相关的偏差/OOS调查。及时回顾异常情况。
  • Perform all company business in accordance with relevant regulations, company policy and procedures. 按照公司正常规定及相关法规等进行所有的公司事务。
  • Assist QC manager to complete other work if needed. 如需要,协助QC经理完成其他相关工作。
Qualifications任职要求:
  • BS degree BS degree in biochemistry, chemistry or a related discipline with 2-3 years of QC relevant experience in vaccine/bio-pharmaceutical industry, or MS in related discipline with at least one years of relevant work experience. 生物化学、化学或其他相关领域学士或硕士学位,7年以上疫苗、生物制药、无菌化药(如大输液)等行业QC相关工作经验。
  • Knowledge of standard requirements for raw material, package material, product testing as stated by GB, CP, GMP. 具有国标、中国药典和GMP等法规关于原辅料包材成品等检测知识。
  • Working knowledge and hands-on technical skills of lab/third party of test operations and testing methods in relevant industry, such as endotoxin testing, TOC, Conductivity test, identification. 有相关工业领域实验室或者第三方检测机构实操经验,如细菌内毒素检测,总有机碳,电导率测试,鉴别。
  • Could do assay develop, analysis method validation. If the candidate has relevant experience, it is an advantage 有能力进行检测方法的开发验证。有相关经验者优先。
  • Ability to analyze data, troubleshoot, train and work closely with other function 具有数据分析、异常结果原因分析的能力,可以被培训并能够和其他部门同事共同合作。
  • Ability to work effectively in QC team. Good written, interpersonal and communication skills required. 具有在QC团队高效工作的能力。良好的写作、团队合作及沟通技巧。
  • Good communication skills in English and Chinese, fluent in speaking, writing and reading in both languages. 良好的英语和中文沟通能力,能流利地说、写、读这两种语言。


职能类别: 药品生产/质量管理 生物工程/生物制药

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