武汉招聘

  

Principal Duties and Responsibilities

  

• Develop and maintain a robust and stable Raw Material team, with high productivity.

  发展和维护一个高效率、稳定、强健的原物料团队

• Closely monitor the raw material testing status, proactively identify and solve any problem or risk which may cause the delay of raw material release.

  密切关注原物料放行状态，主动提前识别并解决可能导致物料放行延迟的任何问题或风险。

• Ensure all the sampling and testing are completed according to relevant SOP and GMP standard.

  确保所有的取样和检测都按照相关SOP和GMP标准执行。

• Lead all the OOS investigation, deviation investigation, close CAPA, change control in a timely manner.

  主导OOS调查、偏差调查，及时关闭CAPA和变更控制。

• Host internal or outside audit.

  接待内部或外部审计。

• Continuously improve lab operation compliance, efficiency, reduce cost.

  持续改善实验室运营符合性、效率和降低成本。

• Any other tasks as assigned by the manager.

  经理安排的其他任务。

  Job Requirements:

• Bachelor’s degree in chemistry, biology or pharmaceutics discipline with 5+ years’ experience in pharmaceutical company quality control department, or Master’s degree with 3+ years’ experience.

  化学、生物学或药学本科5年以上制药企业QC工作经验，或硕士3年以上经验。

• Familiar with USP, EP, JP and ChP requirement on drug substance, excipient, packaging material.

  熟悉USP，EP，JP和ChP对于原料药、辅料和包材的要求。

• Well versed in chemistry or microbiology based testing, with hands-on experience.

  精通化学或微生物检测，有一线操作经验。

• Thorough knowledge of NMPA, EMA and US FDA GMP practices and regulations.

  熟知NMPA，EMA和US FDA GMP法规。

• Excellent oral and written communication skills in English.

  优秀的英文说写沟通能力。

                                                  

鼎康生物是一家领先的CDMO公司，可提供一站式的CMC解决方案，支持从早期药物开发到后期临床研究和商业化cGMP生产。鼎康引进了全球***模块化生物制药工厂Kubio；为客户开发的多个产品已经在全球20多个国家进行临床试验。在不久的将来，鼎康生物总产能将超过140,000L。我们承诺通过技术和生产创新，使全球患者都能负担得起具有国际标准的生物药物，提高治疗水平以改善人类健康。