CSV Validation Engineer - Solothurn, Switzerland

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