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Validation Lead

Amgen · Hyderabad, India

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QualityFull-timeCompany career page

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Role summary

Amgen seeks a Validation Lead to oversee validation activities for data platforms and solutions in a regulated environment. The role involves coordinating qualification and validation processes, developing documentation, and collaborating with cross-functional teams to ensure compliance with company standards and regulatory requirements.

What they're looking for

  • 5+ years testing experience with 2+ years in GMP-regulated validation
  • Demonstrated leadership of software validation projects
  • Proficiency in developing IQ/OQ/PQ protocols, reports, and validation documentation
  • Strong analytical and problem-solving capabilities
  • Excellent verbal and written communication skills
  • Bachelor's or Master's degree in computer science or engineering preferred

What you'll be doing

  • Plan, coordinate, and lead validation activities including qualification of data products and software applications
  • Develop, review, and approve validation plans, protocols, and reports ensuring regulatory compliance
  • Collaborate with cross-functional teams to drive validation activities and meet project timelines
  • Track validation progress and align schedules with product owners and scrum masters
  • Document deviations, manage change control, and identify process improvement opportunities

Privacy & handoff

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What RoleLantern checked

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RoleLantern checked active
RoleLantern checkedNeeds clarity
Date posted16 days ago
Last source check1 day ago
Salary listedNeeds clarity
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