Computer System Validation Expert | Computer System Validation Expert (m/w/d)

Job Summary

This role seeks a Computer System Validation Expert to ensure regulatory compliance across IT systems within a leading pharmaceutical manufacturer. Day-to-day responsibilities include meticulous documentation of all validation activities concerning Business Applications, supporting the qualification of IT infrastructure systems, and managing the creation and maintenance of validation-relevant documents throughout the entire system lifecycle. The expert will collaborate closely with Quality Management and other departments to uphold GxP and compliance requirements, actively supporting internal and external audits and inspections. They will also guide system changes and projects to ensure adherence to GxP and compliance standards. The ideal candidate possesses a degree in Computer Science or Pharmacy, coupled with professional experience in validating computer-aided systems in the pharmaceutical sector. Essential knowledge includes GAMP 5, GMP, GxP, and FDA 21 CFR Part 11. This position offers significant scope for personal responsibility, an attractive compensation package, and flexible working hours within a highly innovative and future-proof industry.