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[武汉]鼎康(武汉)生物医药有限公司

  1. 发布时间:2020-07-28
  2. 工作地点:武汉
  3. 职位类型:全职
  4. 来源:前程无忧(51JOB)
  5. 职位:环境监测与微生物经理/Manager of QC-EM and Microbiology
职能类别:其他

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。


公司简要介绍:

公司名称:鼎康(武汉)生物医药有限公司
公司类型:外资(非欧美)
公司介绍:


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