Beschreibung
CSV (Computer Systems Validation) Engineer - Solothurn, Switzerland
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
Overall Responsibilities:
Working in a remediation project as PQS (CSV Validation Engineer). Be the QA part in the sub projects in an overall remediation project for GxP Systems. Having experience in Software validation of ERP Systems (SAP) is big plus.
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).