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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