Computer System Validation Lead

Overview

On Site
Depends on Experience
Accepts corp to corp applications
Contract - W2
Contract - 24 Month(s)

Skills

CSV
Computer System Validation
Lead

Job Details

Role: Computer System Validation Lead

Location - Raritan, NJ(Hybrid)

 

7-10 years experience in Computer System Validation of EMS and BMS applications

Must have experience in Agile methodology and handled multiple releases in parallel

Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation, experience with EMS/BMS, project management, test script review, test execution review, test defect management.

Has working experience in any one or two of the following domains Tool validation like ServiceNOW, Automation tools, JIRA

Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC

Application of FDA guidance s and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams

Experience in drafting and approving CSV deliverables like Compliance Analysis, Compliance Plan, Test Protocol, Test Report and Compliance Summary Report

Must be familiar with procedures, work instructions, forms and templates

Solid understanding of SDLC, Jira, QTest, automated test tools, code repository like bitbucket and change control/ management systems like ServiceNow

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About Laiba Technologies LLC