IT Quality Validation Consultant - Hybrid
📋 Role Overview & Responsibilities
Description: Hybrid ***Please focus on local candidates. Would consider allowing worker to be based out of Exton if strong candidate has that preference. IT Quality Validation Consultant 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. Must be familiar with 21 CFR Part 11. Consult on Projects. Prepare Project Plans. BS in a technical field and 5 years experience in GxP environment. Requirements: 1) Extensive Pharmaceutical Experience. 2) Extensive experience (10 years plus) in writing IT system validation protocols including IQs/OQs/PQs, project summary report. Will consider candidate 5-7 years. 3) Deep understanding of SDLC and IT/system change management processes. 4) Experienced in writing system implementation project related documentation such as project charter, implementation plan, communication plan, risk management plan. 5) BS degree required. Masters' degree preferred.
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This position is located in Nutley, NJ with potential relocation and sponsorship assistance depending on candidate qualifications.
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