Collins McNicholas

Job Responsibilities:

  • Updating Validations SOPS and Masters Plans to ensure compliance to current and future EU/FDA regulations.  
  • Maintaining an up to date knowledge of relevant regulatory requirements. Interact with other departments to ensure that validation projects are appropriately planned, executed and delivered in a timely manner.
  • Approval of SDLC documentation in line with current regulatory and corporate requirements.       

Experience/Education:

  • Minimum 3rd level Science /Engineering degree. Minimum 2 years’ experience working in a Validations environment.
  • Comprehensive understanding of  Validation principles and practices.  
  • Very good working knowledge of Validations practices, ASTM and relevant EU/FDA regulations.
  • A proven track record that demonstrates the ability to work without direct supervision whilst maintaining adherence to project delivery is fundamental to the role.

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