IT Quality Validation Consultant

Duration: 12 Months+

• 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.

Education:

• BS in a technical field and 5 years’ experience in GxP environment.

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. Masters’s degree preferred.

Shift: Day