Job Description

Key Responsibilities

Implementation & System Support

  • Assist in implementing and supporting the Lorenz DocuBridge Suite
  • Ensure compliance with regulatory requirements (eCTD, NeeS)
  • Collaborate with Regulatory Affairs, QA, IT Security, and vendors to gather and translate business requirements into scalable solutions
  • Support project execution across all lifecycle phases: assessment, configuration, validation, launch, and post-production

Validation & Compliance

  • Develop validation deliverables (validation plans, IQ/OQ/PQ protocols) as per GxP and 21 CFR Part 11
  • Maintain audit trail configurations, user access controls, and role-based privileges to ensure system security and compliance

System Integration & Change Management

  • Support structured document workflows and integrate the solution with Regulatory Veeva RIM
  • Contri...

Ready to Apply?

Take the next step in your AI career. Submit your application to Amgen Technology Private Limited today.

Submit Application