CSV Lead
CSV Lead
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1 Vacancy
Job Description
Job Title- CSV Lead
Job Location - Raritan NJ (Hybrid)
Job Details:
- 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 guidances 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
Employment Type
Full-time
