Beschreibung
Qualification & Validation Engineer/CSV VALIDATION ENGINEER
Location: Grenchen
Tasks:
*Cover the part of the GxP-Compliance in the project for various retrospective validations.
.Creation of the Validation documentation for GxP relevant system elements.
- User requirement specification
- Compliance Plan
- Risk Assessment
- Test Plan
- Technical Specification
- Hardware Qualification Table
- User acceptance Test Script
- Test Report
- Compliance Report
.Support the business organization for the execution of the tests.
.Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
Extended Duties:
.Planning, coordination, execution and reporting of activities related to the project
Requirements:
*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
Language Skills:
.English fluent, German Fluent
Actual Work location: Bettlach and Grenchen (SO)