GxP Test Engineer

NTT DATA, Inc.; Chennai District; On-site; INR 1,500,000 - 2,300,000; Full time

Job summary

NTT DATA seeks an experienced GxP Validation Test Engineer in Chennai to support IQ/OQ/PQ activities and maintain audit-ready documentation within a regulated life sciences environment.

You will prepare test plans, manage defects, ensure traceability, and collaborate with stakeholders to meet regulatory requirements and project priorities.

Qualifications

• 5–8 years of testing, validation, or QA in regulated environments.
• Strong understanding of GxP, GMP, and validation principles.
• Experience with IQ, OQ, and PQ protocols.
• Familiarity with FDA 21 CFR Part 11, EU Annex 11, and data integrity principles.

Responsibilities

• Prepare and maintain test plans, scripts, protocols, evidence, and test summary reports.
• Execute GxP validation testing activities (IQ/OQ/PQ).
• Manage the complete testing lifecycle from preparation to closure, including defect management.
• Establish traceability between requirements and test cases via the Requirements Traceability Matrix.
• Record, track, and coordinate defect resolution with business and technical stakeholders.
• Ensure testing documentation complies with client quality standards and regulatory requirements.
• Maintain inspection-ready validation documents and provide regular status reports.
• Support audit, inspection, and validation-readiness activities.
• Work within staffing plans and client-defined priorities.

Skills

Analytical skills

Documentation

Communication

Stakeholder management

Tools

ALM

Jira

Azure DevOps

Job description

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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,

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 anddigitalinfrastructure 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 is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. For our EEO Policy Statement, please click here . If you'd like more information on your EEO rights under the law, please click here . For Pay Transparency information, please click here .

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