武汉招聘

 

1. Develop and maintain a robust and stable Raw Material team, with high productivity.
2. 发展和维护一个高效率、稳定、强健的原物料团队
3. Closely monitor the raw material testing status, proactively identify and solve any problem or risk which may cause the delay of raw material release.
4. 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。
5. Ensure all the sampling and testing are completed according to relevant SOP and GMP standard.
6. 确保所有的取样和检测都按照相关SOP和GMP标准执行。
7. Lead all the OOS investigation, deviation investigation, close CAPA, change control in a timely manner.
8. 主导OOS调查、偏差调查，及时关闭CAPA和变更控制。
9. Host internal or outside audit.
10. 接待内部或外部审计。
11. Continuously improve lab operation compliance, efficiency, reduce cost.
12. 持续改善实验室运营符合性、效率和降低成本。
13. Any other tasks as assigned by the manager.
14. 经理安排的其他任务。

 

 

Job Requirements:

1. 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.
2. 化学、生物学或药学本科五年以上制药企业QC工作经验，或硕士三年以上经验。
3. Familiar with USP, EP, JP and ChP requirement on drug substance, excipient, packaging material.
4. 熟悉USP，EP，JP和ChP对于原料药、辅料和包材的要求。
5. Well versed in chemistry or microbiology based testing, with hands-on experience.
6. 精通化学或微生物检测，有一线操作经验。
7. Thorough knowledge of NMPA, EMA and US FDA GMP practices and regulations.
8. 熟知NMPA，EMA和US FDA GMP法规。
9. Excellent oral and written communication skills in English.             

10.  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。