Capgemini

GxP Manual Functional Tester

Job Description

Choosing Capgemini means choosing a company where you will be empowered to shape your career in the way you’d like, where you’ll be supported and inspired by a collaborative community of colleagues around the world, and where you’ll be able to reimagine what’s possible. Join us and help the world’s leading organizations unlock the value of technology and build a more sustainable, more inclusive world. 

Your Role

We are seeking an experienced GxP Manual Functional Tester with strong knowledge of GxP compliance, CSV (Computer System Validation), and regulated system testing within the Life Sciences or Pharma domain. The tester will be responsible for validating business applications, documenting evidence, executing test cases, and ensuring compliance with regulatory standards.
  • Strong understanding of GxP (Good Practice) regulations including GMP, GCP, GLP.Experience working in FDA‑regulated environments (21 CFR Part 11, Annex 11).
  • Hands-on experience in:Computer System Validation (CSV), Validation documentation (URS, FRS, RTM, IQ/OQ/PQ, etc.)
  • Experience with end‑to‑end functional testing of enterprise systems.Ability to design, execute, and document Test scenarios, Test cases, Test scripts
    Detailed defect logging and root cause identification.

Your Profile

  • Knowledge of SDLC/STLC and best QA practices.
  • Understanding of Data Integrity principles (ALCOA / ALCOA+).
  • Familiarity with Life Sciences systems such as LIMS, MES, ERP, QMS, or clinical applications.
  • Exposure to API testing or basic SQL for backend validation (optional but beneficial).
  • Experience working in Agile, Waterfall, or hybrid delivery models.
  • Good communication skills for collaborating with business, validation, and compliance teams.

What you will love about working here

  • You can shape your career with us. We offer a range of career paths and internal opportunities within Capgemini group. You will also get personalized career guidance from our leaders.
  • You will get comprehensive wellness benefits including health checks, telemedicine, insurance with top-ups, elder care, partner coverage or new parent support via flexible work.
  • At Capgemini, you can work on cutting-edge projects in tech and engineering with industry leaders or create solutions to overcome societal and environmental challenges. 

Capgemini is an AI-powered global business and technology transformation partner, delivering tangible business value. We imagine the future of organizations and make it real with AI, technology and people. With our strong heritage of nearly 60 years, we are a responsible and diverse group of 420,000 team members in more than 50 countries. We deliver end-to-end services and solutions with our deep industry expertise and strong partner ecosystem, leveraging our capabilities across strategy, technology, design, engineering and business operations. The Group reported 2024 global revenues of €22.1 billion.
Make it real | www.capgemini.com


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