Validation Engineer: CSV, Legacy, GxP, Medical Devices. GERMAN

Vertragsart:
Vor Ort
Start:
ASAP
Dauer:
keine Angabe
Von:
Sentinel IT LLP
Ort:
Basel-Stadt
Eingestellt:
22.03.2014
Land:
flag_no Schweiz
Projekt-ID:
683399

Warning
Dieses Projekt ist archiviert und leider nicht (mehr) aktiv.
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Validation Engineer: CSV, Legacy, GxP, Medical Devices. GERMAN

SENIOR CSV VALIDATION ENGINEER

Overall Responsibilities:
* Project Quality Support in the CSV Equipment Legacy Review
* Project Quality Support in CSV Equipment Remediation Projects
* Team Lead of Site CSV Equipment Team

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
* Team Player
* Excellent Communication skills
* Leadership skills

Language Skills:
*English fluent, German Fluent