Description
CSV, Computer System Validation - SpecialistStart date: asap
Industry: Medical Device
Assignment type: temporary
Location: Switzerland (German Part)
Our client is one of the most significant Medical Device Company based in Switzerland.
They are now seeking a passionate CSV (Computer System Validation) specialist who brings in the expertise to contribute to a professional and motivated environment.
Specialized in new products, processes and technologies, our client is not only known for its innovative and adaptable corporate entertainment, but is also a very desirable employer with more than 1000 motivated employees in the subsidiary.
You're Responsibilities:
- Verification & Validation of a medical device system - development and execution
- Overviewing GxP-Compliance in the project for various retrospective validations.
- You create the Validation documentation for GxP relevant system elements.
- Implement QA / QC for all tests in relation to the project
- Planning, coordination, execution and reporting of activities related to the project
- User requirement specification
- Compliance Plan
- Risk Assessment
- Test Plan
- Technical Specification
- Hardware Qualification Table
- User acceptance Test Script
- Test Report
- Compliance Report
You're Profile:
- Higher education (Engineer or similar) and background in IT
- Experience in similar position or extended experience as executer required.
- Knowledge of national and international regulations and standards
- GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFR, Part 820, Part 11
- CSV Experience in the area of Medical Devices Manufacturing
- Team Player
- Excellent Communication skills