Senior Validation Analyst

Responsibilities

Lead end-to-end validation activities across systems and applications.
Develop and execute validation plans, test cases, and protocols (IQ/OQ/PQ where applicable).
Ensure compliance with regulatory standards and internal quality policies.
Perform risk-based assessments and validate system controls.
Execute functional, regression, and UAT testing.
Maintain validation documentation including traceability matrices and reports.
Support audits and regulatory inspections with required evidence.
Collaborate with QA, development, and business teams.

Requirements

5–8+ years in validation, QA, or testing in regulated environments.
Strong understanding of SDLC/STLC and validation lifecycle.
Experience with test planning, execution, and defect management tools (e.g., JIRA, ALM).
Knowledge of regulatory frameworks (e.g., SOX, GxP or equivalent).
Strong documentation and analytical skills.
Ability to work independently and manage priorities.

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