New Jersey Area
We are seeking a Sr. Quality/IT Infrastructure Qualifications Consultant to work with our team onsite at our client site on a long term assignment. You will work on IT QA infrastructure qualifications and conduct periodic review activities and work with Quality/Validation staff to oversee infrastructure qualifications, as well as support and facilitate compliance/validation activities.
Essential Duties and Responsibilities
- 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