• Be responsible for quality monitoring of EM or Microbiology Lab routine test, method validation, work schedule and management.

  • Routine quality monitoring of EM, such as water system, process Gas System, clean room, pure steam system and so on；

  • Routine test and validation, such as Bioburden, Sterility and so on；

  • Raw records and reports review；

  • Lab management: materials, instruments, methods. EM related, training；

  • Make work plans according to the schedule and track their execution；

  • Project management for microbiology test.

• Be responsible for documents draft and management

  • Documents for quality monitoring of EM, microbiology test and lab management related;

  • Draft related documents and follow the standards and requirements;

  • Deal with deviation, change control ,establish CAPA and ensure its effective execution ,other actions of GMP system related;

• Keep micro-lab in order and ensure micro-lab activities comply with GMP/EHS/IP and other requirements.

Other tasks assigned by director.

上班地址：富特中路288号

所属部门：上海质量控制部