IT Infrastructure Specialist

4 days ago

Meerut, Uttar Pradesh, India beBeeSystem Full time ₹ 18,00,000 - ₹ 24,00,000
Job Description

We are seeking a skilled IT Infrastructure Specialist to manage the validation of data platform applications.

This role involves experience in Agile methodology and handling multiple releases in parallel.

Responsibilities:

  • Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation is essential.
  • Experience with data platform applications project management, test script review, test execution review, test defect management is necessary.
  • Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the system development life cycle.
  • Application of FDA guidelines and industry standards (i.e., GAMP) is required.
  • Strong understanding of 21 CFR Part 11 and risk-based approach with the ability to guide the project teams is essential.
  • Experience in drafting and approving CSV deliverables like compliance analysis, compliance plan, test protocol, test report, and compliance summary report is necessary.
  • Familiarity with procedures, work instructions, forms, and templates is required.
  • Solid understanding of system development life cycle, Jira, QTest, automated test tools, code repository like Bitbucket, and change control/management systems like ServiceNow is necessary.

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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