Continue to make an impact with a company that is pushing the boundaries of what is possible. At NTT DATA, we are renowned for our technical excellence, leading innovations, and making a difference for our clients and society. Our workplace embraces diversity and inclusion – it’s a place where you can continue to grow, belong, and thrive. Your career here is about believing in yourself and seizing new opportunities and challenges. It’s about expanding your skills and expertise in your current role and preparing yourself for future advancements. That’s why we encourage you to take every opportunity to further your career within our great global team. Your day at NTT DATA The Senior Software Quality Assurance is an advanced subject matter expert, accountable for ensuring that the design and software adhere to company standards in every phase of the development process. This role consults various stakeholders in the development and execution of exploratory and automated tests to ensure product quality. Key Responsibilities Document and validate software installed on lab instruments globally in accordance with EMA guidelines Transition ongoing software management (Legacy SOP’s) to PPD IT software management SOPs Document current-state software configurations and requirements Key Activities to manage: Gathering and documenting requirements Authoring validation test cases Developing software specifications Creating infrastructure and data flow diagrams Performing risk assessments Validation Execution: Create, execute, and document validation protocols (Installation Qualification/IQ, Operational Qualification/OQ, Performance Qualification/PQ) for laboratory and manufacturing instrument software. Documentation & Compliance: Generate validation plans, reports, User Requirement Specifications (URS), and traceability matrices to ensure compliance with 21 CFR Part 11, GAMP 5, and GxP standards. Testing & Debugging: Perform functional, integration, regression, and data integrity testing to ensure software functions as intended. Risk Management: Participate in risk assessments (e.g., FMEA) to identify and mitigate software risks. Change Control: Evaluate software upgrades or modifications and implement change control procedures to maintain validated status. Troubleshooting: Analyze test deviations, perform root cause analysis, and work with developers to resolve issues. Required Qualifications & Skills Education: Bachelor’s degree in Computer Science, Engineering, or Life Sciences. Experience: 2–5 years of experience in computer system validation (CSV) or software validation within a regulated industry (pharmaceutical, medical device, biotech). Regulatory Knowledge: Strong understanding of FDA, EMA, and GMP guidelines. Technical Skills: Knowledge of laboratory information management systems (LIMS), chromatography data systems (e.g., Empower), and data integrity principles. Analytical Skills: Excellent technical writing and problem-solving Workplace type: Equal Opportunity Employer NTT DATA is proud to be an Equal Opportunity Employer with a global culture that embraces diversity. We are committed to providing an environment free of unfair discrimination and harassment. We do not discriminate based on age, race, colour, gender, sexual orientation, religion, nationality, disability, pregnancy, marital status, veteran status, or any other protected category. Accelerate your career with us. Apply today