IT Quality Validation / System Validation / Pharmaceutical (hybrid)

  • Nutley, NJ
  • Posted 13 days ago | Updated 8 days ago

Overview

Hybrid
$65
Contract - W2
Contract - 12 Month(s)
No Travel Required
Unable to Provide Sponsorship

Skills

validation
21 CFR
GXP
Pharma

Job Details

I am working on this long term contract position for one of my major Pharmaceutical clients . They are looking for string IT Quality validation and Pharmaceutical industry experience.


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.
Sumeet Chhatwal
Sr Technical Recruiter
Lenmar Consulting, Inc (a Kellton Tech Company)
1440 Plaza Five, Suite 1440
Jersey City, NJ 07311
Ph: Ext 4012, Cell
Email -