Computer System Validation
📋 Role Overview & Responsibilities
NO C2C/ H1B Candidates please. ONLY W2 candidates.
Description: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 of experience in GxP environment.
Requirements:Extensive Pharmaceutical Experience with 10 years plus in writing IT system validation protocols including IQs/OQs/PQs, project summary report. 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. Masters’s 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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