Computer System Specialist

1 day ago

Bengaluru, Karnataka, India beBeeSystem Full time ₹ 15,00,000 - ₹ 25,00,000

Are you looking for a challenging role in Computer System Validation?

We are seeking a skilled specialist to join our team in this exciting opportunity.

The ideal candidate will have experience with Data Platform applications, including Data Lake, Data Warehouse, and Data Bricks.

You must have worked with Agile methodology and handled multiple releases in parallel.

About the Job

  • You will be responsible for ensuring the validation of computer systems meets regulatory requirements.
  • Experience with project management, test script review, test execution review, and test defect management is essential.
  • You will guide the project team on applicable project deliverables based on project type and category.
  • You will apply FDA guidelines and industry standards (GAMP).
  • You will have a strong understanding of 21 CFR Part 11 and Risk-Based Approach.
  • You will draft and approve CSV deliverables like Compliance Analysis, Compliance Plan, Test Protocol, Test Report, and Compliance Summary Report.
  • You must be familiar with procedures, work instructions, forms, and templates.
  • You will have a solid understanding of SDLC, Jira, QTest, automated test tools, code repository (Bitbucket), and change control/management systems (ServiceNow).

Key Skills Required

  • 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

What We Offer

We offer a competitive compensation package and opportunities for career growth and development.

This is an excellent opportunity for a motivated individual to take on new challenges and contribute to the success of our organization.

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