.Come to one of the biggest IT Services companies in the world!! Here you can transform your career! Why to join TCS? Here at TCS we believe that people make the difference, that's why we live a culture of unlimited learning full of opportunities for improvement and mutual development. The ideal scenario to expand ideas through the right tools, contributing to our success in a collaborative environment. We are looking for Validation Lead, who wants to learn and transform his career. In this role you will:Validation Strategy: Develop and implement a validation strategy for digital solutions, ensuring alignment with regulatory requirements, industry best practices, and customer's internal standards.Validation Plans and Protocols: Create validation plans and protocols for digital solutions, including data pipelines and interfaces, automation applications, data-driven models, and statistical tools. Ensure that all validation activities are properly documented and executed according to established procedures.Risk Assessment: Conduct risk assessments to identify potential risks associated with the use of digital solutions in a GMP environment. Develop risk mitigation strategies and ensure that appropriate controls are in place.Testing and Qualification: Collaborate with cross-functional teams to perform testing and qualification activities for digital solutions, particularly with QA SMEs. This includes executing test cases, analyzing results, and documenting findings. And much better if you stand out for:? English fluently Demonstrate knowledge of current GxP requirements and documentation standards with the ability to write validation docs Strong knowledge in validation principles and practices in a GMP environment. Experience in validating digital solutions, including Release Management processes and controls, as well as validation of statistical and data-driven models. Familiar with test automation process and development. Knowledge of pharma and/or cell & gene therapy supply chain processes is a plus Desirable Skills:Demonstrate knowledge of current GxP requirements and documentation standards with the ability to write validation docs. Knowledge of pharma and/or cell & gene therapy supply chain processes is a plus.Displays skills and capabilities in the area of business partnering and/ or product management. Proactively lead the validation efforts throughout the E2E process and work in a cross-functional and global team. Demonstrates ability to perform detail-oriented work with a high degree of accuracy and able to explain complex concepts with clarity and simplicity
