Certified Computer Systems Validation Specialist

6 days ago

Dublin, Dublin City, Ireland beBeeValidation Full time €75,000 - €90,000
Job Description

We are seeking a seasoned Certified Computer Systems Validation Specialist to join our team for an exciting project. As a key member of the team, you will be responsible for developing and executing validation protocols for computer systems and software applications.


This is a unique opportunity to utilize your technical expertise and experience in computer system validation to ensure compliance with regulatory guidelines and internal policies.



Required Skills and Qualifications
  • Bachelor's degree in Computer Science, Engineering, or a related field.
  • Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
  • Minimum 5 years of experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology.
  • Familiarity with validation methodologies, including risk-based validation approaches.
  • Proficiency in creating and executing validation protocols and documenting validation activities.
  • Excellent analytical and problem-solving skills, with attention to detail.
  • Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.


Benefits
  • Mid-Senior level position with opportunities for professional growth and development.
  • A chance to work on high-profile projects with experienced professionals in the industry.
  • A competitive contract rate.


Others

This position requires a strong understanding of computer systems validation principles, practices, and regulatory requirements. The ideal candidate will have excellent communication and collaboration skills, with the ability to work independently and manage multiple projects simultaneously.

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