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) -