Certified Auditor - Computer System Validation

Job Summary

To support a growing Compliance and Quality Assurance team, the full-time Certified Auditor - Computer System Validation will conduct audits and provide guidance on compliance with health authority regulations related to computer systems, AI assurance, and data integrity, with the flexibility to work remotely from various Eastern European locations.

Key responsibilities

• Conduct audits of pharmaceutical, medical device, clinical, and software development organizations for compliance with relevant regulations
• Author policies and procedures while providing remediation guidance for compliance in computer system validation and AI assurance
• Develop and deliver original content and training materials on current topics in computer system validation and data integrity

Required qualifications

• BSc or higher in a life sciences or related discipline
• Certified auditor with a minimum of 10 years auditing experience, including at least 30 audits in relevant areas
• Minimum of 15 years in the pharmaceutical or medical device industry
• Fluency in English and ideally one other EU language
• Expert knowledge of FDA, EU, and MHRA GxP regulations and industry best practices