Beschreibung
My client, a global top 10 Medical Device company is currently seeking a CSV Validation Engineer for a 6 months project with a possible extension.Overall Responsibilities:
Working as PQS (CSV Validation Engineer) for the validation of legacy software and software validation of production equipment. Creation of all needed documents to get the system complaint with the regulations.
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 (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: Italian & English fluent, German is a plus
If you feel suitable I am looking forward to hearing from you.
Campaign Ref: CH
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