Company Name

HCL Technologies Ltd ( Hyderabad )

Job Description

• Responsibilities
  • Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation.
  • Experience with Data Platform applications project management, test script review, test execution review, test defect management.
  • 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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