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Sr Validation Engineer

Sr Validation Engineer

Amgen Technology Private Limited

1 - 9 years

1 - 9 Lacs

Hyderabad Telangana India

Posted:1 month ago| Platform: Foundit logo

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Skills Required

GxP Validation Veeva Vault Test Case Management

Work Mode

On-site

Job Type

Full Time

Job Description

Key Deliverables:

Define and execute validation strategies for GxP-regulated IT systems
Create and manage validation documentation using Veeva VM Testing Vault
Execute test cases, track defects, and ensure compliance with regulatory standards
Generate reports and dashboards on validation progress and defect metrics

Role Responsibilities:

Collaborate with system architects, QA, and business teams to align validation plans
Maintain audit-ready documentation and manage workflows in validation tools
Support end-users and conduct training on validation systems and best practices
Ensure adherence to FDA 21 CFR Part 11, GxP, and global regulatory frameworks

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