IT Validation Consultant

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Job description

We are looking for an experienced IT Validation Consultant to develop and grow the validation client department. 
Roles & Responsibilities:

  • Provide Validation expertise in Validation strategy and approach 
  • Ensure regulatory compliance applicable to computerized systems. 
  • Approve the risk analysis by integrating the regulatory impacts. 
  • Supervise the Validation team, from planning to the production of the system. 
  • Approve the Validation plan, the Validation report, each qualification protocol and reports (in accordance with the Validation plan)
  • Manage anomalies (if applicable) and approve the action plans put in place 
  • Approve the production of the IS
Education and Experience
  • Bachelor’s degree in computer science, engineering life science or related field  
  • 2 years experience with CSV validation lifecycle management, validation documentation development and 1 year project management, using a risk based methodology.
  • 2 plus years Pharmaceutical manufacturing or Medical Device industry experience in computer systems validation, process validation, QA or compliance functions.
  • Excellent understanding and experience with industry regulations, standards, and guidelines

Summary

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