Description
We are looking for a
CSV engineer (m/f)
Reference: -en
Start: asap
Duration: 3 MM++
Place: in the Central Switzerland/Swiss Plateau region
Branch: Medizintechnik
Your tasks:
- Assist in validation activities associated with the manage supplier UK project providing an SaaS ERP system directly to the customer to ensure that all compliance issues and requirements of the companies validation policies and procedures are addressed
- Serve as a technical expert for the validation process and responsibilities to ensure compliance
- Ensure accuracy and maintenance of the company's software validation documentation for this project and review and approve validation plans, protocols, summary reports and other documentation associated with validations
- Ensure all validation activities and documents are authorized and all validation activities are carried out and reported in a timely manner
Your qualifications
- Experience in software validation
- Profound knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
- Solid understanding of GMP
- Working experience in validation computer systems for use in a FDA-regulated environment
- Ability to lead and give directions to validation projects and teams
- Profound working experience in a regulated industry and experience in carrying out validations
Skills:
- Qualification/validation specialist
Keywords: Spezialist Validierung und Spezialisierung