Beschreibung
CSV Validation Engineer - Solothurn, Switzerland
Skills:
Higher education (Engineer or similar) and background in IT
Experience 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
CSV Experience in the area of Medical Devices Manufacturing
Team Player
Excellent Communication skills
Overall Responsibilities:
Project Quality Support in the CSV Remediation Project
Project Managment & Leader Skills
Experienve in SAP related validation activities.
Tasks:
Cover the part of the GxP-Compliance in the project.
Creation of the Validation documentation for GxP relevant system elements
Support in the creation of 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