Beschreibung
Validation Engineer to execute review and propose remediation of historical validation records associated with equipments ensuring that all compliance issues and requirements of the clients Validation Policies and Procedures are addressed.
In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations
Medical devices pregressed experience is needed, minimum of 2 - 5 years working in a regulated industry a minimum 2 of which has been spent carrying out validations.
English is essential, Italian and German would be a luxury.