Comissioning, Qualification, And Validation Manager
As the Manager of Commissioning, Qualification, and Validation (CQV) for the Buriti project at Takeda, led by Tessler Engenharia, I played a crucial role in the successful construction, implementation, and technology transfer of the biotechnology building for Hemobrás in Goiana, PE.- Demonstrated effective leadership and project management skills in overseeing commissioning, qualification, and validation activities, ensuring strict compliance with relevant regulations and guidelines such as FDA, EMA, and Anvisa.- Developed and executed comprehensive qualification and validation strategies and plans for new biological products, from the project phase to large-scale production.- Provided hands-on supervision to the qualification and validation team, offering technical guidance, setting clear objectives, and ensuring adherence to tight deadlines.- Ensured alignment of strategies to comply with Good Manufacturing Practices (GMP) and other regulatory standards.- Fostered collaboration among development, production, and quality assurance teams to safeguard the integrity of the qualification and validation process.- Proactively identified and implemented continuous improvements in qualification and validation processes, resulting in enhanced efficiency and cost reduction.- Possessed extensive expertise in all areas of Equipment Qualification and Validation of Computerized Systems (Laboratory, Utilities, Upstream, Downstream, Fill and Finish, HVAC, Automation, ERPs, etc.).As the CQV Manager, I successfully led the Buriti project by effectively managing all aspects of commissioning, qualification, and validation. My strong leadership skills, coupled with technical expertise and regulatory knowledge, ensured the project's adherence to industry standards and its timely completion.
