Job Seekers, Please send resumes to email@example.com
· 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