High-Performance Information System Professional

1 week ago

Kanpur, Uttar Pradesh, India beBeeSystem Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

We are seeking a highly skilled Computer System Specialist to lead our team.

  • Develop and maintain extensive knowledge of CSV creation, revision, and documentation.
  • Lead project management, test script review, test execution review, and test defect management for data platform applications.
  • Guide project teams on the right set of applicable project deliverables based on project type and category while catering to the SDLC.
  • Apply FDA guidelines and industry standards (GAMP).
  • Ensure strong understanding of 21 CFR Part 11 and Risk-Based Approach to guide project teams.
  • Draft and approve CSV deliverables like Compliance Analysis, Compliance Plan, Test Protocol, Test Report, and Compliance Summary Report.
  • Familiarize procedures, work instructions, forms, and templates.
  • Understand SDLC, Jira, QTest, automated test tools, code repository (Bitbucket), and change control/management systems (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

This is an exciting opportunity to leverage your expertise in computer system validation and contribute to our success.

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