Computer System Validation Specialist CSV

My client is one of the top leading biopharma companies in the UK with the purpose to impact positively in global health and provide a workplace where people feel inspired and challenged to be the best they can be valued, and ;

We have an exciting opportunity for a well-detailed and collaborative Computer System Validation Specialist (CSV) to join the The role will require you to provide QA and validation support to automation and IT projects.

• Provide technical advice and take quality decisions to establish processes and controls that meet regulatory, cGMP, and Quality Management System
  
• Accountable for the validation and validation maintenance of computerised systems associated with Processes, Facilities, Equipment, Manufacturing Execution Systems (MES), and IT
  
• Ensure compliance with GAMP, 21 CFR Part 11, Annex 11, and data integrity
  
• Plan validation activities to ensure customer and business needs are met in alignment with the overall project plans and
  
• Provide oversight of Quality Assurance processes within projects validation documentation, deviation handling,
  
• Knowledge application in active risk management and problem-solving for both new and existing
  
  

Requirements

Requirements

• BSc in a Science, Engineering or Computer Science related
  
• 3 years of experience in validation, Quality Assurance/ Production
  
• Prior experience working to compliance to GAMP5, 21 CFR Part 11, Annex
  
• Prior experience in controls, automation, and/or IT systems
  
• Ability to work in a team and
  

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