武汉招聘

岗位描述：
? Lead, develop and maintain a robust and stable microbiology and environmental monitoring team, with high productivity. 
管理，发展和维护一个高效率、稳定、强健的微生物和环境监测团队
? Responsible for GMP compliance of the team.  Ensure all the testing are completed in a timely manner according to relevant SOP and GMP standard.
负责团队的合规性，确保所有的检测都按照相关SOP和GMP标准按时执行;
? Manage microbial testing activities in raw materials, intermediate, DS and DP. 
带领团队进行原辅料，中间品，原液和制剂的微生物检测。
? Design and oversee microbiological validations as needed for various samples
指导各类样品微生物检测的验证工作
? Develop and implement Standard Operating Procedures for new processes and methods.
开发落实新的流程和方法
? Implement and manage the EM programs for controlled areas.
制定和实施环境监测计划
? Contribution to validation, qualification/requalification of the clean utilities/facilities
对洁净区的验证提供建议和审核
? Act as Site Subject Matter Expert for Microbiology and Aseptic Control
担当微生物和无菌控制的SME
? Closely monitor the environmental monitoring contamination control status, proactively identify and solve any problem or risk.
密切关注环境监测污染控制状态，主动提前识别并解决任何问题或风险。
? 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 director.
总监安排的其他任务。

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。