Description
We are looking for a
Qualification and Validation Engineer (m/f)
Reference: -en
Start: asap
Duration: 3 MM
Place: in Ticino
Branch: Medizintechnik
Your tasks:
- Provision of support for the validation activities associated with software equipment, ensuring that all compliance issues and requirements of the client are addressed
- Implementation of initiatives in the Validation Process that will deliver customer value at lowest cost
- Review and approval of validation master plans, protocols, summary reports and other documentation associated with validations, as appropriate for each validation exercise
- Ensuring that all validation activities and documents are authorised and appropriate compliance approval is gained
- Facilitation, encouragement and coordination of continuous improvement with respect to validation activities
- Ensuring compliance through assisting in audits
- Informing the management about significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee health & safety, company operations, and/or the environment
Your qualifications
- A degree in an appropriate discipline (e.g. Engineering, Information Systems, or an IT qualification) with a broad technical/educational skill base and substantial related experience
- Knowledge of bespoke validation, process knowledge and documentation
- Working experience of validation computer systems for use in a FDA regulated environment
- 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
- Working experience in carrying out validation and/or testing activities
- English and Italian language skills, both in spoken and written for
Skills:
- Qualification/validation specialist
Keywords: CSV Validation Audits Engineer Process knowledge documentation 21 CFR CFR