Specialist Qualification and Validation (m/f)

- Validation Specialist to provide support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment
- Support Validation process
- Cross-functional support for Quality Systems
- Review and approve Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations, as appropriate for each validation exercise
- 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
- Working experience of validation computer systems for use in a FDA regulated environment
- Active team member in Validation activities Methodology/Certification Requirements
- Qualification in an appropriate discipline (e.g. Engineering, Information Systems or Life Science with additional IT qualification)

Weitere Qualifikationen: Qualification/validation specialist