GxP Test Engineer

NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now.

We are currently seeking a GxP Test Engineer to join our team in Chennai, Tamil Nādu (IN-TN), India (IN).

Job Summary

We are looking for an experienced GxP Validation Test Engineer to support testing and validation activities within a regulated life sciences environment. The role will be responsible for preparing compliant testing documentation, executing IQ, OQ, and PQ activities, managing defects, and maintaining audit-ready evidence under the direction and priorities of the Client.

Core Responsibilities

• Prepare and maintain test plans, test scripts, protocols, evidence, and test summary reports.
• Execute GxP validation testing activities, including Installation Qualification, Operational Qualification, and Performance Qualification.
• Manage the complete testing lifecycle, including preparation, execution, defect management, reporting, and closure.
• Establish and maintain traceability between business requirements and test cases through the Requirements Traceability Matrix.
• Record, track, triage, and coordinate the resolution of defects with business and technical stakeholders.
• Ensure testing documentation complies with Client quality standards, procedures, and regulatory requirements.
• Maintain accurate, complete, and inspection-ready validation documentation.
• Provide regular testing status reports, defect trends, risks, and quality metrics to the Client.
• Support audit, inspection, and validation-readiness activities.
• Work within the agreed staffing plan, allocated capacity, and Client-defined priorities.

Required Skills and Experience

• 5–8 years of experience in software testing, computer system validation, or quality assurance within a regulated environment.
• Strong understanding of GxP, GMP, validation principles, and regulated testing practices.
• Hands-on experience executing IQ, OQ, and PQ protocols.
• Experience creating test plans, scripts, validation reports, and traceability matrices.
• Strong knowledge of defect management, test evidence, and validation documentation controls.
• Familiarity with regulatory expectations such as FDA 21 CFR Part 11, EU Annex 11, and data integrity principles.
• Experience using test management and defect-tracking tools such as ALM, Jira, Azure DevOps, or similar platforms.
• Strong analytical, documentation, communication, and stakeholder-management skills.

Preferred Qualifications

• Experience in pharmaceutical, biotechnology, medical device, or life sciences organisations.
• Knowledge of Computer System Validation and risk-based validation methodologies.
• ISTQB, quality, validation, or GxP-related certification is preferred.