Job Responsibilities/工作职责
1. Lead, develop and maintain a robust and stable microbiology team, with high productivity.
管理，发展和维护一个高效率、稳定、强健的微生物团队；
2. 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；
3. 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；
4. 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；
5. Act as Site Subject Matter Expert for Microbiology and Aseptic Control.
担当微生物和无菌控制的SME；
6. 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；
7. Ensure all micro tests of all IPC, DS, DP and stability sample analysis are completed within timeline.
确保所有中间体，原液，制剂和稳定性样品的微生物检测能够按时完成；
8. Ensure all micro tests are verified to support production of products for clinical or commercial use.
确保所有用于临床或商业化产品的微生物放行方法都是经过确认的；
9. Ability to recognize, trouble-shoot, and resolve problems with equipment or individual micro tests.
能够解决设备故障或者单个微生物实验上的技术难题；
10. Handle the quality event such as change control, deviation and CAPA related to the testing and ensure all are closed before due date.
负责处理与检测相关的质量事件，例如变更，偏差和纠正和预防措施, 并确保其在到期日期前关闭；
11. Ensure that the documentation and laboratory processes are in a constant state of regulatory compliance and inspection readiness.
确保文件和实验室流程始终处于法规遵从性和检查准备就绪状态。
12. Host internal or outside audit.
接待内部或外部审计；
13. 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；
14. Any other tasks as assigned by the director.
总监安排的其他任务；
15. Comply with the company's information security management related system and requirements.
遵守公司关于信息安全管理的相关制度和要求。