职位详情
QC Scientist
1.1-1.4万
外企德科
上海
3-5年
硕士
05-02
工作地址

诺华上海园区1

职位描述
"服务描述
1. Understand Analytical Method key documentation for Drug Product (both chemical products and biological products), includes the test procedure, validation report, instrument, critical reagents et. al. ., and joins the technical communication with global analytical experts for technical exchange.
理解制剂产品(包含化学药与生物药产品)相关的关键分析方法文件,包括分析方法,验证报告,分析仪器,关键试剂等,能够参与与全球分析方法开发专家的技术交流和沟通。 40%
2. Work together with project leaders on drafting the quality specification based on the Global provided analytical method, and Chinese Pharmacopeia requirements. 与项目经理合作,基于Global提供的分析方法文档,结合中国药典相关要求,起草本地注册检验质量标准。 30%
3. Proof-reading of key CMC related documentation. 参与关键CMC 技术文档中文译本的校对工作。 20%
4. Perform the sample calculation based on provided technical document to support the QC testing. 基于技术文档,理解并计算QC 质检测试需要的样品量计算。 10%
5. Monthly report on project review, analytical method hand-over, and capacity analysis. 协助管理项目月度报告,分析方法月度总结,以及团队项目分配,工时报告等行政性事物。5%
6. Contribute to documentation management lifecycle via Subway (A documentation management system), including documents upload, review and approval, et. al. 参与Subway 系统的文件管理,包含文件的上传,审阅,批准等文档生命周期管理。 5%
服务要求:
Education (minimum/desirable):
Minimum: Analytical Scientist with Master's Degree or Excellent Bachelor with 5 Years Experience
Desirable: Master's in Analytical Chemistry (Chemical or Biological)
Languages: Good Reading and Written English ( Good Spoken English is preferred).
Experience/Professional requirement:
l Solid knowledge in Analytical Chemistry or equivalent experience in Analytical development, QC skills. 分析化学教育背景或3年分析方法开发,QC实验室经验。
l Advanced knowledge of Analytical laboratory and/or technical tools. 熟悉分析方法开发的实验室技能及技术工具。
l Solid Experience in Project Management. 具有相对丰富的项目管理经验。
l Proficient in English literature reading. 熟练的英文文献检索阅读能力。
l Good presentation skills and scientific/technical writing skills.
l Good communication skills
地址:上海金科路4218号

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