System Validation Specialist

2 days ago


Coimbatore, Tamil Nadu, India beBeeData Full time ₹ 10,00,000 - ₹ 16,00,000
System Validation Expert

The ideal candidate will have experience in computer system validation of data platform applications, Agile methodology, and multiple releases in parallel.

Key Responsibilities:

  • Develop extensive knowledge in CSV creation and revision of CSV documentation.
  • Manage Data Platform applications project management, test script review, test execution review, and test defect management.
  • Guide the project team with applicable project deliverables based on project type and category while catering to the SDLC.
  • Apply FDA guidelines and industry standards (i.e., GAMP).
  • Understand 21 CFR Part 11 and Risk Based Approach and guide the project teams.
  • Draft Compliance Analysis, Compliance Plan, Test Protocol, Test Report, and Compliance Summary Report.
  • Be familiar with procedures, work instructions, forms, and templates.
  • Have solid understanding of SDLC, Jira, QTest, automated test tools, code repository like Bitbucket, and change control/management systems like ServiceNow.

Required Skills:

  • Computer System Validation
  • Test Case Review, Validation Plan, Validation Summary Report
  • 21 CFR part 11
  • Validating SAP, ERP, LIMS, Data Platforms
  • GAMP Guidelines, GxP Guidelines, Industry Standards


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