Computer System Validation – CSV

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profile Job Location:

Raritan, NJ - USA

profile Monthly Salary: Not Disclosed
Posted on: 30+ days ago
Vacancies: 1 Vacancy

Job Summary

Position: Computer System Validation CSV

Location: Raritan NJ-(Hybrid 3 Days in a Week)


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 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

Position: Computer System Validation CSV Location: Raritan NJ-(Hybrid 3 Days in a Week) Key Responsibilities: 7 years experience in Computer System Validation of ServiceNow Operational Technology tools validation Must have experience in Agile methodology and handled multiple releas...
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Key Skills

  • Python
  • SOC
  • Debugging
  • C/C++
  • FDA Regulations
  • Minitab
  • Technical Writing
  • GAMP
  • OS Kernels
  • Perl
  • cGMP
  • Manufacturing