Beschreibung
CSV Validation Engineer - SwitzerlandI am currently seeking a CSV Validation Engineer to become an important part in one of the biggest Medical Devices projects in Switzerland at the moment.
You will be working in a remediation project as PQS (CSV Validation Engineer). The project is separated in two phases. Creation of risk analysis in the first project phase and in the second phase revalidations of GxP Systems.
Tasks:
- Support and consulting during projects handling GxP critical computer systems.
- Creation of the Validation documentation for GxP relevant systems.
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations.
Extended Duties:
- Planning, coordination and execution of activities in cross-plant projects (e.g. qualification of IT systems and infrastructure needs, validation of software, etc.).
Requirements:
- Higher education (Engineer or similar) and background in IT and at least 5 years work experience
- Responsible in similar position or extended experience as executer required.
- Knowledge of national and international regulations and standards, e.g. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFR Part 820, Part 11
Language Skills: German & English fluent
I am a specialized recruiter and I am currently taking care of more than 20 freelance projects within the Medical Devices area in Switzerland. For more information about this role or jobs within related specialist areas please send me your CV with your hourly rate expectation for immediate consideration. You can reach me on or m.muller'at'realstaffing.com
Keywords: CSV Validation Engineer, Medical Devices, Risk analysis, revalidations, GxP, Validation, IT, GAMP5, ISO 13485, ISO 62304, FDA QSR, CFR Part 820, Part 11, German, English, Freelance, Switzerland
Campaign Ref: CH
To find out more about Real please visit www.realstaffing.com