Validation and GMP Inspection Supervisor
职位编号: 77021624

发布日期: 2021-02-24

电子邮箱: cv_bayer@vip.sina.com;chuhan.zhang1.ext@bayer.com
工作年限: 5-7年
招聘人数: 1人
工作地点: 北京
公司: 拜耳医药保健有限公司
主要职责:

工作职责

 

  • Update site VMP and maintain VMP database routinely, manage Sys. No., track the progress of qualification and validation execution.
  • Is responsible for creating periodic qualification documents, coordinate departments for execution. Participate in review Q&V protocols and reports from compliance perspective, especially enhance the management to process validation and cleaning validation as new requirements from up-to-date GSOPs and guidances.
  • Enhance qualification management of site self-inspectors and provide related training, enhance self-inspection's scope and extent, enhance the CAPA management.
  • Provide dedicate trainings periodically at site level about those findings from self-inspections and qualification&validaiton.
  • Add the on-site inspection of qualification and validation during execution, enhance the documentation management.
  • Participate or organize related departments to do risk assessment when there is upgrading of current systems or new technical system.
  • Organize Third Party to perform site monitoring and maintainence of pest control, coordinate departments for deviation investigation about pest control if applicable.
  • Update SOP according to GSOP and local requirements; some related work like, to review monthly maintenance report.

 

任职要求

 

  • University graduate or above in pharmacy or related major
  • 5 years and above in quality department, or experience for implementation of qualification and validation
  • Proven time management and communication skills.  
  • High degree of autonomy in tasks, but team-worker and good skills in cross-functional work relationships
  • GMP/regulations, Pharmaceutics and qualification/ validation related
  • Knowledge of GMP standards and related national / international regulations and guidelines.
  • Knowledge of production process and quality control.
  • Good at computer operation.
  • Fluent Spoken and good written English.
   
   

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