Senior Validation Consultant

2 weeks ago

Dublin, Dublin City, Ireland beBeevalidation Full time €80,000 - €110,000
Computer System Validation Specialist

This is a highly specialized role that requires expertise in validating computer systems to ensure they comply with regulatory requirements. The ideal candidate will have experience in developing and executing validation protocols for software applications, as well as proficiency in creating and maintaining validation documentation.

Key Responsibilities:
  • Validation Protocol Development: Develop and execute validation protocols for computer systems and software applications to ensure compliance with regulatory guidelines.
  • Collaboration and Risk Assessment: Collaborate with cross-functional teams to identify critical system functionalities and potential vulnerabilities, and perform risk assessments and impact analyses to inform validation activities.
  • Validation Documentation: Create and maintain validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports.
  • Compliance Monitoring: Conduct periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures.

The successful candidate will have a strong background in validation methodologies, including risk-based approaches, and be proficient in creating and executing validation protocols and documenting validation activities.

Requirements:
  • Education: Bachelor's degree in Computer Science, Engineering, or a related field.
  • Regulatory Knowledge: Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
  • Experience: 5+ years experience in computer system validation within a regulated industry.
  • Validation Methodologies: Familiarity with validation methodologies, including risk-based validation approaches.
  • Communication Skills: Proficiency in creating and executing validation protocols and documenting validation activities.

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