Computer System Validation Expert (all gender)

📋 Description

• Plan, lead and document validation activities according to GAMP 5 as well as FDA 21 CFR Part 11 and
• Ensure that all GxP and GMP requirements are met throughout the entire system lifecycle
• Work closely with IT, QA and specialist departments to continuously ensure regulatory compliance
• Derive appropriate validation strategies from risk analyses and actively support audits and

🎯 Requirements

• Completed degree in computer science, engineering, pharmacy or a comparable qualification
• Relevant experience in the validation of computerized systems in the pharmaceutical industry
• Strong knowledge of GAMP 5, GMP, GxP and FDA 21 CFR Part 11, and experience with systems such as
• Proficient in German and English, both written and spoken

🎁 Benefits

• Flexible working hours and mobile working possible