Description
Our client is a leading Medical Device organisation. They are currently seeking a CSV specialist in the area of automation systms for manufacturing equipment.Location: Germany
Start: ASAP
Travel 40%
Duration: 13 weeks
Overall Responsibilities:
• Project Quality Support in the CSV Equipment Legacy Review
• Project Quality Support in CSV Equipment Remediation Projects
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, co-ordination, execution and reporting of activities related to the project.
Requirements:
• 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 (not only Pharma)
Language Skills:
• English & German fluent
This is an excellent opportunity to work for a global Medical Device organisation!