Description
We are looking for a
Computer System Validation Specialist (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Place: in Southern Germany or Austria
Branch: Medizintechnik
Your tasks:
- GxP computer system validation (CSV)
- Support the SDLC Software Development Life Cycle (Detailed Design, UAT Script Testing, security deliverables, BIA and disaster recovery)
- Risk Management (ISO 14971)
- Approving specific computer system validation documentation
- Planning and implementation of qualification/validation activities
- Ensure compliance through assisting in audits
Your qualifications
- Experienced with validation processes and responsibilities
- Knowledge of 21 CFR 820, 21CFR Part 11, FDA QSR, ISO 13485, ISO 14971, ISO 60601 , ISO 62304 and GAMP5
- Working experience with validation computer systems for use in a FDA-regulated environment
- Engineer Degree or similar with IT Background
- Profound experience in Computer System validation (CSV) and SDLC (systems development life cycle)
- Profound experience within Medical Devices Industry
- Profound experience in Quality Management Systems
- Solid experience with Project Management Tools such as MS Project
- Fluent in English and German
Skills:
- Qualification/validation specialist