Computer System Validation - 12 month

Description

CSV Validation Engineer - 12 month

My client, a global life-science manufacturing company with a unique combination of expertise in biotechnology, medical devices and pharmaceuticals is currently looking for a Computer System Validation Consultant for a 12 month project.

Tasks:
- Support Creation Work Frame for CSV Equipment
- 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
- Planning, coordination and execution of activities in cross-plant projects (eg. 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
- Responsibility in similar position or extended experience as executer required.
- Knowledge of national and international regulations and standards, eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11
-English fluent

If you are interested in this role, please do not hesitate to send your CV in WORD.

<p>To find out more about Real please visit <a href="http://www.realstaffing.com">www.realstaffing.com</a></p>