IT Validation and Risk Management Expert

2 weeks ago


Limerick, Limerick, Ireland Regeneron Ireland Dac Full time
Required Skills and Qualifications
  • Detailed knowledge of 21CFR11 and Annex 11 as well as MHRA, FDA, and WHO data integrity guidelines
  • Solid understanding and experience with Computer Systems Validation and/or IT Auditing
  • Understanding of the interdependencies of change management, deviation, and continuous improvement
  • Knowledge of global organizations, process mapping, and process improvement
  • Analytical skills with ability to analyze information of considerable difficulty and draw valid conclusions


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