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Instrument Software Validation Analyst

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NTT DATA

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Location:
Belgium , Diegem

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Category:
IT - Software Development

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Contract Type:
Not provided

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Salary:

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Job Description:

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.

Job Responsibility:

  • 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
  • Gathering and documenting requirements
  • Authoring validation test cases
  • Developing software specifications
  • Creating infrastructure and data flow diagrams
  • Performing risk assessments
  • Create, execute, and document validation protocols (Installation Qualification/IQ, Operational Qualification/OQ, Performance Qualification/PQ) for laboratory and manufacturing instrument software
  • Generate validation plans, reports, User Requirement Specifications (URS), and traceability matrices to ensure compliance with 21 CFR Part 11, GAMP 5, and GxP standards
  • Perform functional, integration, regression, and data integrity testing to ensure software functions as intended
  • Participate in risk assessments (e.g., FMEA) to identify and mitigate software risks
  • Evaluate software upgrades or modifications and implement change control procedures to maintain validated status
  • Analyze test deviations, perform root cause analysis, and work with developers to resolve issues

Requirements:

  • Bachelor's degree in Computer Science, Engineering, or Life Sciences
  • 2–5+ years of experience in computer system validation (CSV) or software validation within a regulated industry (pharmaceutical, medical device, biotech)
  • Strong understanding of FDA, EMA, and GMP guidelines
  • Knowledge of laboratory information management systems (LIMS), chromatography data systems (e.g., Empower), and data integrity principles
  • Excellent technical writing and problem-solving

Additional Information:

Job Posted:
May 16, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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