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.