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·         Minimum 10 years information technology and/or pharmaceutical industry experience with exposure to a broad range of GxP validation activities

·         such as document control, computer systems, vendor assessment, and change control.

·         5 years’ experience performing testing and system validation work in a cGMP environment

·         Must possess excellent technical writing, documentation and communication skills

·         Must have experience qualifying/validating an Identity and Access Management system and some level of technical understanding of such architecture.

·         Familiarity with FDA requirements for computerized systems, including 21 CFR Part 11 as well as GAMP guidance documents