Beschreibung
* Project Quality Support in the CSV Equipment Legacy Review* Project Quality Support in CSV Equipment Remediation Projects
* 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
* 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 (young team!)
* Excellent Communication skills
* Pragmatist
* Motivated, energetic
* English & German fluent
Schlagwörter:
Validation, Medizintechnik, Validierung, Test
Kontaktperson: Account Manager Herr Bekir Sabuncuo
FERCHAU Engineering GmbH
Niederlassung Villingen-Schwenningen
Siederstraße 49
78054 Villingen-Schwenningen