Beschreibung
CSV Specialist / 6 Months Project / 100%International medical devices company, is looking for a CSV specialist for 6 months project with start asap.
Overall Responsibilities:
Working in an remediation project as PQS (CSV Validation Engineer). Creation of Risk analysis in the first project phase, 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
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
Responsility 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
Language Skills: German & English fluent
If you feel suitable for this project, I´m looking forward to hearing from you.
Campaign Ref: CH
To find out more about Real please visit www.realstaffing.com