Beschreibung
Für ein Unternehmen aus der Medizintechnik suchen wir ein engagierten Freelancer mit max. 5 Jahren Erfahrung in CSV und Technische Dokumentation.Telefoninterviews sind Zeitnah möglich. Wir suchen ab sofort!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, coordination, 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) * Team Player* Excellent Communication skills * Pragmatist * motivated, energetic Language Skills: * English & German fluent
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