Instrument Software Validation Analyst

Descripción del puesto:

Make an impact with NTT DATA
Join a company that is pushing the boundaries of what is possible. We are renowned for our technical excellence and leading innovations, and for making a difference to our clients and society. Our workplace embraces diversity and inclusion - it's a place where you can grow, belong and thrive.

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:

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 part of NTT Group, which invests over $3 billion each year in R&D.

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. Join our growing global team and accelerate your career with us. Apply today.

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