Computer System Validation Lead

3 days ago

Hyderabad, Telangana, India beBeeSystem Full time ₹ 20,00,000 - ₹ 25,00,000

Greetings from our organization

We are seeking a skilled Computer System Validation Manager to lead our offshore team in driving validation deliverables.

Key Responsibilities:
  • Oversee end-to-end validation lifecycle for GxP applications including planning, execution, and reporting.
  • Develop and review validation deliverables: URS, FRS, Risk Assessments, Test Protocols, RTMs, Validation Plans, and Summary Reports.
  • E nsure traceability and completeness of test cases aligned with risk levels.
  • Manage defect management and ensure proper documentation of test results and evidence.
  • Coordinate change control processes for minor and major system updates.
  • Review and approve operational procedures and SOPs for validated systems.

This role requires a strong understanding of Agile and Waterfall methodologies in validation context, experience with tools like ALM, DMS, JIRA, and excellent stakeholder management skills.

Requirements:
  • 15+ years in CSV for GxP applications
  • A deep understanding of Agile and Waterfall methodologies in validation context
  • Experience with tools like ALM, DMS, JIRA
  • Excellent stakeholder management skills

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