Beschreibung
SAP CSV Qualification And Validation Engineer German Speaking
CSV Lead for SAP OTC
Overall Responsibilities:
- Working in a remediation project as a CSV Lead for SAP OTC.
Tasks:
- Cover the part of the GxP-Compliance in the project.
- Creation of the Validation documentation for GxP relevant system elements.
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
Extended Duties:
- Planning, coordination, execution and reporting of activities related to the project
Requirements:
- Higher education (Engineer or similar) and background in IT
- Responsility in similar position or extended experience as executer required.
- Knowledge of national and international regulations and standards
- GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11
- SAP CSV Experience
- Excellent Communication skills