Expert Computer Systems Professional

1 week ago

Dindigul, Tamil Nadu, India beBeeComputerSystemSpecialist Full time ₹ 1,20,00,000 - ₹ 2,00,00,000
Job Title: Computer System Specialist

This is an exciting opportunity to leverage your technical expertise as a skilled Computer System Specialist.

The ideal candidate will have experience in computer system validation of data platform applications, including data lake, data warehouse, and data bricks. They must also be familiar with agile methodology and have handled multiple releases in parallel.

  • Extensive knowledge of CSV, CSV auditing, creation, and revision of CSV documentation.
  • Experience with data platform applications project management, test script review, test execution review, and 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 of 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.
Required Skills and Qualifications:
  • 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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