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Test Lead - Validation Engineer (QA Analytics)

Full Remote
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Leads validation testing for QA Analytics solutions in the pharmaceutical industry, ensuring compliance with GxP and regulatory standards. Develops test cases, validates dashboards/data pipelines, and collaborates with Agile teams. Requires 5+ years in GMP validation, full-stack technical expertise, and strong documentation skills.

Key Highlights
Ensure compliance with GxP and regulatory standards in pharmaceutical QA analytics
Develop and execute test cases for validation under Agile framework
Collaborate with cross-functional teams including developers and business analysts
Key Responsibilities
Develop and execute test cases aligned with user stories and system specifications
Perform formal verification and validation activities including regression, stability, and data extraction tests
Ensure traceability between requirements, test cases, and executed results
Author and maintain GxP-compliant test cases in qTest
Validate dashboards, data pipelines, and analytics outputs for accuracy and compliance
Document defects, deviations, and resolutions in alignment with SOPs and change control processes
Collaborate with Agile team members, developers, business analysts, and quality representatives
Coordinate with global stakeholders to ensure harmonized validation practices
Technical Skills Required
GxP/Pharmaceutical Validation Full-Stack Development Test Automation (qTest, qTest, Vera)
Nice to Have
Experience with React, Angular, and JavaScript for data visualization
Strong understanding of GxP and regulatory standards in the pharmaceutical industry

Job Description

The Expert Test Engineer/Validation Engineer plays a critical role in ensuring that the QA Analytics solution meets regulatory, business, security, and technical requirements. This role is embedded within the Core Agile Team and collaborates with Business Owners, BTQA, BUQA, and developers to execute validation deliverables under the Agile Development Life Cycle (ADLC) framework.

Develop, refine, and execute test cases aligned with user stories and system specifications. Perform formal verification and validation activities across QA Analytics solutions, including regression, stability, and data extraction tests. Ensure traceability between requirements, test cases, and executed results.

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