CSV Process Vaidation - Leads & Consultants

Baden-Württemberg  ‐ Vor Ort
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Beschreibung

CSV Process Validation Consultants & Leads - Long Term Contract - Germany

We are building a new team for a major greenfield and looking for CSV Process Validation specialists

Knowledge of:
o Prospective, Concurrent & Retrospective validation -
o FDA's Quality System Regulations -
o ISO 13485: 2016 (or latest) -
o All applicable sub-sections of 21 CFR Part 820 but mainly -
§ 820.3(z)(1) Process validation -
§ 820.75 requirements for process validation-
§ 820.30(g) design validation -
§ 820.70(g) equipment req

European standards

o Device Reporting process (MDR - Medical Device Reporting) -

o Knowledge of Risk Management process -

o Risk Analysis as a part of Design validation [820.30(g)] -

Desirable:

Six Sigma (process) -

Start
ab sofort
Dauer
12 - 24 month +
Von
Networking People (UK)
Eingestellt
31.08.2017
Projekt-ID:
1408432
Vertragsart
Freiberuflich
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