Senior Chemistry Professional

Category:  Quality
Location: 

Tianjin, Tianjin, CN

   

Are you motivated by driving innovation for the life-changing benefit of patients? Are you ready to help transform the treatment paradigm for a broad range of chronic diseases that currently rely on injection-based therapies? Then this is your moment. Apply now and join  Novo Nordisk. Together we can create life-changing innovation. Together we can make it happen.

 

The position

  • Thorough overview of key analytical processes, e.g.: Chemical testing for Water/Excipient/Drug products, sampling of APIs/Excipients.                                                                                关键分析过程的全面概览,如:水/辅料/成品的检验流程,API与原辅料的取样流程。
  • Perform and document all work in accordance with GMP, site, and corporate procedures and policies. Write methods of analysis and other operational documents, translate key operational documents from English into Chinese. And drive continously improvement.
    所有操作和记录文件符合GMP、工厂和公司流程政策。编写分析方法和其他操作文件,将关键操作文件的英文版本翻译成中文。并持续的优化流程。
  • Lead Investigation for OOS/OOT/OOE results and set up corrective actions.                                 主导超标准/超趋势/超期望结果的调查与纠正措施。
  • Perform complex problem solving related to testing of insulin products, excipients and water for pharmaceutical use & sampling of APIs/Excipients. Be bold to make decisions.                                解决化学实验室在胰岛素产品、辅料和制药用水相关实验及原辅料取样方面的疑难问题。敢于决策。
  • Identify gaps between pharmacopeia and QCC process, ensure compliance for local process and analytical method, clarify pharmacopeia understanding, foresee new Ch.P. according to USP/Ph. Eur. trend, and send efficient/related comment/suggestion to Authority.                                                         识别化学现有流程和药典之间的缺陷,确保本地流程及分析方法的符合性,澄清药典的理解,依照美国药典/欧洲药典的趋势,对新版中国药典进行前瞻,对当局提出有效/相关的评论/建议。
  • Drive project management related to delivery, improvement and compliance etc, drive local signal.          主导与供货、简化、合规相关的项目管理与本地signal.
  • Be familiar with Chinese GMPs and regulatory requirements related to testing methods and laboratory.       熟悉测试方法和实验室相关的中国GMP和法规要求。
  • Be the responsible for laboratory method transfer, method validation or method verification.                 作为实验室方法转移、方法验证或确认的负责人。
  • Leading to perform the method validation and Pharmacopeia comparison.                                  可以带领及主导实验室进行方法验证和药典对比。
  • Setting up and managing QC Lab test process (at least more than 15 test methods) for Novo Nordisk insulin products produced in PS Site Tianjin and serve as a method SME.                                            建立及管理诺和诺德天津工厂生产的胰岛素产品的实验的流程(至少负责胰岛素实验室十五种以上的分析方法),担任方法SME
  • Train other end users to operate equipment and to execute methods of analysis, and perform matured PC for sustainlable compliance and improvement.                                                              培训其他最终用户如何操作设备和进行实验,并能成熟的执行PC以确保持续的合规及优化。
  • Maintain a safe working environment and work in compliance with all NN and local Chinese safety and environmental regulations.
    维护安全的工作环境并且按照所有诺和诺德和中国当地安全和环境法规工作

 

Qualifications

  • 4-yr (BS) D Degree in Chemistry, Pharmacy, Engineering or related field                        化学、药剂学、工程学或其他相关领域学科 4 年本科教育学士学位
  • Fluent in written and spoken English

良好的英语书写和沟通能力

  • Minimum 7 years of pharmaceutical QC Lab experience

至少 7 年制药厂质量控制实验室经验

  • Previous experience with project management is desirable                                                具有项目管理的经验
  • Previous experience with pharmacopoeia methods for water/excipients, product analysis ( USP/Ph.Eur./JP/Ch.P.)                                 具有药典关于水/辅料/产品的分析方法的经验(方法包括美国/欧洲/日本/中国药典)
  • Previous experience with GMP requirement

具有GMP要求的经验

 

Working at Novo Nordisk

At Novo Nordisk we recognise that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and the communities we operate in.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.

Are you motivated by driving innovation for the life-changing benefit of patients? Are you ready to help transform the treatment paradigm for a broad range of chronic diseases that currently rely on injection-based therapies? Then this is your moment. Apply now and join  Novo Nordisk. Together we can create life-changing innovation. Together we can make it happen.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.