Beschreibung
Our client is a high profile medical device manufacturer. They currently have a requirement for a CSV Lead for SAP OTC for one of their sites in mainland Europe.
Overall Responsibilities:
- Working in a remediation project as a CSV Lead for SAP.
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
- Leadship for the QA Sub Project Team
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
- Team Player
- Excellent Communication skills
Language Skills: English fluent, German is a plus