IT Quality Validation Consultant

Duration: 12+ Months

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’s degree preferred.

Education:

BS degree required. Masters’s degree preferred.

Shift:

1st shift