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- BS Degree IN Technical field and extensive Pharmaceutical experience.
- 5-7 years experience 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.
- Prepare Change Control documentation. Execute test scripts.
- Perform risk assessments. Must be familiar with 21 CFR Part 11..
- Prepare Project Plans. BS in a technical field and 5 years experience in GxP environment.
IT Quality Validation Consultant - Nutley, United States - Infotree Global Solutions
Description
No H1B and/or C2C Please
Make sure to apply with all the requested information, as laid out in the job overview below.
Job Title: IT Quality Validation Consultant / Computer System Validation Consultant (Pharma/Biotech)
W2 Contract & Hybrid role
Work Location: Nutley, NJ
One of our leading Pharmaceutical client is looking for an IT Quality Validation Consultant / Computer System Validation Consultant, whowill Prepare computer validation documents such as Validation Plans, User Requirements, Configuration Specifications, Test Protocols, and Summary Reports. Prepare Change Control documentation.
Required Skill & Experience:
Responsibilities: