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Expert Advisory Consultant for System Validation

3 months ago

Ruddington, Nottinghamshire, United Kingdom Ideagen Full time

Senior Advisory Consultant - Computer System Validation (CSV)

Ideagen is a leading organization dedicated to enhancing safety and operational efficiency across diverse sectors. We are on the lookout for a Senior Advisory Consultant to oversee our Computer System Validation initiatives.

Key Responsibilities:

  • Oversee and manage formal evaluations of computerized systems
  • Draft and maintain project-specific CSV documentation
  • Examine and validate data integrity within CSV documentation
  • Coordinate project schedules and deliverables
  • Engage in process enhancement and ongoing improvement efforts

Required Skills and Qualifications:

  • 3-5 years of expertise in computer system validation
  • Degree in a scientific, health, or IT-related discipline
  • Familiarity with systems utilized in the life sciences sector
  • Comprehension of regulatory standards such as 21 CFR Part 11
  • Experience in managing regulatory audits and inspections
  • Proficient in Microsoft Office Suite