Woodcliff Lake, NJ, USA
icrunchdata Network
Job Title: IT Quality Validation Consultant Duration: 12 Months (with possibility of extension) Location: Woodcliff Lake, NJ Primary Responsibilities: Prepare computer validation documents such as Validation Plans, User Requirements, Configuration Specifications, Test Protocols, and Summary Reports. Prepare Change Control documentation. Execute test scripts. Perform risk assessments. To be on this position you should: Must be familiar with 21 CFR Part 11. Experience Consult on Projects, Prepare Project Plans. BS in a technical field and 5 years’ experience in GxP environment. Primary Requirements: Extensive Pharmaceutical Experience. Extensive experience (10 years plus) in writing IT system validation protocols including IQs/OQs/PQs, project summary report. Will consider candidate 5-7 years. Deep understanding of SDLC and IT/system change management processes. Experienced in writing system implementation project related documentation such as project charter, implementation plan, communication plan, risk management plan. BS degree required. Master’s degree preferred. Job Requirements: