Gxp Functional Test Lead

3 weeks ago

Chennai India Capgemini Full time

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 bya 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 organizationsunlock the value of technology and build a more sustainable, more inclusive world. Your Role We are seeking an experienced GxP Functional Test Lead to manage and execute testing activities for applications and systems operating under GxP compliance standards. The ideal candidate will have strong knowledge of GxP regulations, validation processes, and hands-on experience in functional testing within regulated environments such as pharmaceuticals, life sciences, or healthcare. - Strong understanding of GxP compliance and CSV principles. - Hands-on experience in functional testing for regulated environments. - Expertise in test documentation (Test Plans, Protocols, Reports) per GxP standards. - Familiarity with FDA 21 CFR Part 11, Annex 11, and other regulatory frameworks. - Proficiency in test management tools (e.g., HP ALM, JIRA). - Ability to lead teams and manage testing deliverables in a validated environment. Your Profile - Exposure to automation testing in GxP environments (e.g., using tools like Tricentis Tosca, Selenium). - Knowledge of Agile methodologies and hybrid delivery models. - Experience with data integrity principles and electronic records/e-signatures compliance. - Familiarity with SAP, LIMS, or other enterprise systems in life sciences. - Strong communication, stakeholder management, and audit support skills. What You'll 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 a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.

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