Beschreibung
Task:- 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
- Project Quality Support in the CSV Equipment Legacy Review
- Project Quality Support in CSV Equipment Remediation Projects
Requirements (Must have):
- 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 (young team)
- Excellent Communication skills
- Pragmatist
- motivated, energetic
- fluent in english and german
Beginn: asap
Dauer: 19.12.2014
Branche: Medizin/Healthcare