Demo

Computer Validation Specialist

Robert Half
New Haven, CT Full Time
POSTED ON 1/17/2025
AVAILABLE BEFORE 4/17/2025

The Computer Systems Validation Specialist will validate computer systems compliant with regulatory standards. The role involves planning, executing, and documenting software system validation, collaborating cross-functionally, and supporting imaging CRO services.

Responsibilities include :

  • Develop test planning and protocols for computer systems to ensure compliance
  • Conduct risk assessments to identify potential systems that impact quality or safety
  • Ensure compliance with GxP regulations
  • Supporting the System Development Life Cycle (SDLC)
  • Develop IQ / OQ / PQ test protocols for functionality and integrity
  • Manage systems changes through change management processes
  • Complete documentation for validation activities
  • Assist with regular audits and inspections

Qualifications include :

  • Bachelor's degree in computer science, Information Technology, Engineering, or related field.
  • Advanced degrees or certifications in quality management or regulatory affairs a plus.
  • Three to five years of experience in computer system validation within a regulated sector.
  • Knowledge of FDA 21 CFR Part 11 and other relevant regulations.
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