System Validation Specialist

2 days ago


Dublin, Dublin City, Ireland beBeeSystemValidation Full time €76,881 - €90,990
Job Description">

As a CSV Validation Specialist, you will play a pivotal role in ensuring the integrity and compliance of computerized systems in a cutting-edge pharmaceutical environment. This is an excellent opportunity to utilize your expertise in system validation and work collaboratively with cross-functional teams to drive quality and excellence.

Required Skills and Qualifications">
  • Bachelor's degree in Computer Science, Engineering, or a related field.
  • 5+ years of experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology.
  • Strong knowledge of regulatory guidelines, including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
  • Familiarity with various validation methodologies, including risk-based approaches.
  • Proficiency in creating and executing validation protocols and documenting all validation activities.
Benefits">

This role offers a unique opportunity to work in a dynamic and innovative environment, with a strong focus on quality and excellence. You will have the chance to collaborate with experienced professionals, develop your skills and expertise, and contribute to the success of our organization.

Others">

As a CSV Validation Specialist, you will be responsible for developing and executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for various computer systems and software applications. You will also work closely with IT, Quality Assurance, and Operations teams to ensure adherence to regulatory guidelines and internal policies.



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