Computer System Validation

Job Description

Key Responsibilities:

•    7+  years’ experience in Computer System Validation  of ServiceNow Operational Technology tools validation

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

•    Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation

•    5+ years of experience in validating  SAP application implementation, 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