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.

About NTT DATA

NTT DATA is a $30 billion business and technology services leader, serving 75% of the Fortune Global 100. We are committed to accelerating client success and positively impacting society through responsible innovation. We are one of the world's leading AI and digital infrastructure providers, with unmatched capabilities in enterprise-scale AI, cloud, security, connectivity, data centers and application services. our consulting and Industry solutions help organizations and society move confidently and sustainably into the digital future. As a Global Top Employer, we have experts in more than 50 countries. We also offer clients access to a robust ecosystem of innovation centers as well as established and start-up partners. NTT DATA is a part of NTT Group, which invests over $3 billion each year in R&D.

Whenever possible, we hire locally to NTT DATA offices or client sites. This ensures we can provide timely and effective support tailored to each client’s needs. While many positions offer remote or hybrid work options, these arrangements are subject to change based on client requirements. For employees near an NTT DATA office or client site, in-office attendance may be required for meetings or events, depending on business needs. At NTT DATA, we are committed to staying flexible and meeting the evolving needs of both our clients and employees. NTT DATA recruiters will never ask for payment or banking information and will only use @nttdata.com, @nttdatafed.com and @talent.nttdataservices.com email addresses. If you are requested to provide payment or disclose banking information, please submit a contact us form,  .

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