Validation Engineer (21 CFR 820) (21 CFR 11)

Vertragsart:
Vor Ort
Start:
ASAP
Dauer:
6-12 months+
Von:
Paribus Global Limited
Ort:
Bern
Eingestellt:
08.05.2013
Land:
flag_no Schweiz
Projekt-ID:
533428

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Dieses Projekt ist archiviert und leider nicht (mehr) aktiv.
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Validation Engineer (21 CFR 820) (21 CFR 11)

Validation Engineer (21 CFR 820) (21 CFR 11) required to provide support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment - ensuring that all compliance issues and requirements of the Validation Policies and Procedures are addressed.

The ideal Validation Engineer (21 CFR 820) (21 CFR 11) should have in-depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry. High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations. Working experience of validation computer systems for use in a FDA regulated environment.

Non-Technical Profile Requirements:
Must be able to lead and give direction to Validation Projects and Teams. Individual must also be an active team member in Validation activities Methodology/Certification Requirements.