Industry Consulting Manager

NTT DATA BUSINESS SOLUTIONS; Bengaluru; On-site; INR 1,500,000 - 2,300,000; Full time

Job summary

NTT DATA BUSINESS SOLUTIONS in Bengaluru seeks an experienced GxP Validation Test Engineer to support testing and validation within a regulated life sciences environment. You will prepare compliant documentation, execute IQ/OQ/PQ, manage defects, and maintain audit-ready evidence under client direction.

The role requires strong knowledge of GMP/GxP, regulatory expectations (FDA 21 CFR Part 11, EU Annex 11), and experience with ALM/Jira/Azure DevOps for traceability and defect tracking.

Qualifications

• Experience in software testing or quality assurance within a regulated environment.
• Hands-on IQ, OQ, and PQ protocols execution.
• Ability to create test plans and validation reports.
• Maintain traceability matrices between requirements and test cases.
• Familiarity with FDA 21 CFR Part 11 and EU Annex 11.
• Strong documentation and stakeholder-management skills.

Responsibilities

• Prepare and maintain test plans, scripts, and evidence.
• Execute GxP validation testing activities (IQ, OQ, PQ).
• Manage the complete testing lifecycle from preparation to closure.
• Maintain Requirements Traceability Matrix traceability.
• Record, track, and triage defects with stakeholders.
• Ensure documentation complies with quality standards and regulatory requirements.
• Maintain inspection-ready validation records.
• Provide regular testing status reports and quality metrics.
• Support audit, inspection, and validation-readiness activities.
• Work within staffing plan and client-defined priorities.

Skills

GxP Validation

IQ/OQ/PQ testing

Regulatory compliance

Defect management

Traceability matrices

Documentation skills

Regulated environment

Tools

ALM

Jira

Azure DevOps

Job description

We are currently seeking an Industry Consulting Manager to join our team in Bangalore, Karntaka (IN-KA), India.

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

• 58 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.