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Specialist IS Business Analyst

Amgen·Hyderabad

Pay not statedJunior levelFull-time

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About the role

Lead the validation team in a GMP High Salesforce application and serve as the accountable leader for validation governance, GxP compliance, RTM traceability, inspection readiness, and quality oversight. Drive compliant delivery through strong validation leadership, risk-based decision making, and operational excellence while developing a high-performing validation team.

What you'll do

  • Lead validation strategy, governance, and execution for GxP-regulated applications, computerized systems, and digital platforms
  • Ownership & oversight for validation activities, ensuring compliance with internal SOPs, regulatory requirements, and industry standards
  • Establish and maintain end-to-end traceability between requirements, risks, test evidence, defects, and compliance documentation through RTM governance
  • Ensure inspection of readiness and support internal audits, regulatory inspections, CAPA, deviation management, and change control activities
  • Complete ownership of validation strategy, testing scope and end-to-end system validation

What you need

  • SOP writing
  • Internal audit
  • GMP
  • Salesforce
  • Any graduate

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