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Looking for candidates that are strong in SW validation and in tool validation. Please note that as part of tool validation we need someone who can write requirements/user needs and perform risk analysis, as well as writing plans, protocols and reports.  Furthermore, very  good written communication skills are needed.

 

·         High level scope is writing a validation plan, high level user requirements for about 5-10 small tools (they would need to learn and understand the tools)

·         write some test procedures, execute the tests, and

·         write validation reports

·         Help in PMA submissions

Domain experience with 21 CFR. 814, 21 CFR. 820