Coordinate and manage hardware, software, network resources and services required for the existence, operation and management of an compliant enterprise IT environment
Conduct periodic review and evaluate processes, SOPs, documentation; corrective/remediation actions.
Assist Staff with the development of deliverables needed for IT infrastructure Qualifications.
College degree and 7 plus years of Quality, Validation and IT infrastructure qualifications related experience
Significant experience conducting reviews of systems/software and equipment for compliance
Proven experience with regulatory guidelines & insuring compliance (FDA/GAMP/Part 11)
Outstanding communication, analytic, and organizational skills with attention to details
Ability to effectively work independently in a deadline driven team environment
Demonstrated technical competence through serving as a Lead/Advisory resource
Information Technology Other
Tagged as: IT Infrastructure Qualifications Validation SME (Pharmaceutical)
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