Beschreibung
CSV Lead Consultant
Edelway is a Swiss IT Services Consultancy. Our global multinational end-client based in Solothurn is currently looking to hire a CSV Lead Consultant on a long-term basis.
Working language: English. German is a plus.
Full time engagement at least until end of 2014.
Starting Date: ASAP
THE ROLE:
- 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
- Planning, coordination, execution and reporting of activities related to the project
YOUR PROFILE:
- 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
- English fluent, German is a plus
If it sounds like your next challenge, send your CV to Kristina and we will contact you shortly to discuss it further.
Keywords: SAP, CSV, Pharma, Compliance, GxP, Schweiz, Switzerland