IT System Validation Manager

2 weeks ago


Limerick, Limerick, Ireland Regeneron Full time
Validation and Compliance Specialist

This position is responsible for ensuring IT systems and programs are compliant with regulatory requirements. The ideal candidate will have experience with computer systems validation and/or IT auditing.

Responsibilities:
  • Compliance monitoring and trending of failures
  • Investigating and troubleshooting problems
  • Reviewing and approving deviation notifications and change control
  • Supporting Quality Risk Management initiatives
  • Developing and reviewing Quality Assurance Agreements
  • Presenting at audits and providing subject matter expertise
Qualifications:
  • Bachelor's degree in a relevant field
  • Minimum 3 years of experience in a related field
  • Experience with computer systems validation and/or IT auditing
  • Detailed knowledge of 21CFR11 and Annex 11 guidelines

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