武汉招聘

职位描述：
1、 Implement the law and regulations on drug quality management, organize
and standardize the quality management of drug production in the enterprise; organize to establish and improve the quality management system of drug production in the enterprise, and monitor the system to ensure its effective operation;
贯彻执行药品质量管理的法律、法规，组织和规范企业药品生产质量管理工作；织
建立和完善本企业药品生产的质量管理体系，并对该体系进行监控，确保其有效
作;
2、Strictly implement quality control and management in accordance with GMP
requirements,  formulate quality management guidelines and improve quality
management measures, and conduct quality supervision;
严格按照GMP要求实施质量控制与管理，制订质量管理方针和改进质量管理措
施，进行质量监督；
3、 Support and supervise other aspects of quality issues, such as verification,
deviations, complaints, file systems and change management procedures, as well as quality control lab’s activities;
支持和监督其他方面的质量问题，如验证、偏差、投诉、文件系统和变更管理程序，及质量控制实验室的活动；
4、 Facilitate internal & external communication on quality issues, including
organizing GMP self-inspection and annual quality review, organizing of identify and report the quality accident, reporting the results, communicate with suppliers to ensure good/stable quality;
促进质量问题的内外部沟通，包括定期组织GMP自检和年度质量评审，组织质量事故识别和报告，与供应商沟通质量要求，以确保良好/稳定的质量。
5、 Responsible for quality management team building, daily management and
training.
负责质量管理团队建设、日常管理和培训工作。

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。