CSV Lead for SAP OTC

For a 7 month project with our customer in Solothurn, we are looking ASAP for a

CSV Lead for SAP OTC

Tasks:

- Working in a remediation project as a CSV Lead for SAP OTC.
- 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
- Responsibility 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 CFR Part 820, Part 11.
- SAP CSV Experience.
- Excellent Communication skills
- Language Skills: English fluent, German is a plus

Are you interested in this position? Then we are looking forward to receiving your application.