Join NTT DATA's innovative team as a GxP Test Engineer in Chennai, Tamil Nadu. This role is pivotal in supporting testing and validation within the regulated life sciences sector. You will be instrumental in preparing compliant documentation, executing critical validation phases (IQ, OQ, PQ), and managing defects, all while ensuring adherence to client directives and priorities.

Key responsibilities include developing and maintaining comprehensive test plans, scripts, protocols, and summary reports. You will conduct Installation, Operational, and Performance Qualification (IQ, OQ, PQ) activities, managing the entire testing lifecycle from preparation through to closure. Establishing traceability between requirements and test cases using a Requirements Traceability Matrix is essential, as is meticulous defect tracking, triaging, and resolution coordination. Ensuring all testing documentation meets client quality standards and regulatory requirements is paramount. Providing regular status updates, defect analysis, and risk assessments to the client will also be a core part of your role. You will also support audits and contribute to validation readiness activities, operating within agreed capacity and client priorities.

A minimum of 5–8 years of experience in software testing, computer system validation, or quality assurance within regulated environments is required. A robust understanding of GxP, GMP, validation principles, and regulated testing practices is crucial. Proven hands-on experience with IQ, OQ, and PQ protocol execution, coupled with proficiency in creating test plans, scripts, validation reports, and traceability matrices, is expected. Strong knowledge of defect management, test evidence, and validation documentation controls is necessary. Familiarity with regulatory expectations like FDA 21 CFR Part 11, EU Annex 11, and data integrity principles is beneficial. Experience with test management and defect-tracking tools such as ALM, Jira, or Azure DevOps is required, alongside strong analytical, documentation, communication, and stakeholder management skills.