Site Validation Specialist

2 hours ago


Sligo, Sligo, Ireland beBeeValidation Full time €80,000 - €120,000
Site Validation Specialist

The ideal candidate for this role will possess a strong understanding of quality assurance and validation principles, as well as experience in implementing and maintaining site validation programs.

Key Responsibilities:
  • Coordinate the implementation and active participation in the site Validation Program and general Quality Assurance activities
  • Validate and quality assure site equipment, utilities, processes, and software in compliance with cGMP standards
  • Generate and execute Site Validation Master Plans, Project Validation Plans, and schedules
  • Generate validation protocols and final reports to cGMP standards, validation investigations, and implement corrective actions
  • Review and approve quality documents and test data, manage validation, exception event, and change control processes
  • Maintain validation equipment and perform cross-training within the team
  • Participate in continuous improvement programs to improve manufacturing, quality, safety, and training systems
Requirements:
  • Qualification and/or degree in engineering or scientific discipline
  • 3+ years of validation/Quality experience in medical device plastics processing, moulding, or assembly operations
  • Knowledge of cGMP and regulatory requirements relating to the medical device industry
  • Strong communication, presentation, and troubleshooting skills
  • Effective interpersonal and organizational skills
  • Ability to work independently and in a team environment


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