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.

- Execution of equipment qualification, following established procedures and guidelines, to ensure compliance and reliability of all equipment used in the processes.- Conducting validation of computerized systems, including the development and execution of tests and protocols to ensure the integrity, safety, and functionality of the systems used in the company.- Experience in equipment qualification in areas such as laboratory, utilities, upstream, downstream, fill and finish, HVAC, automation, ERPs, among others.- Active participation in defining strategies for qualification and validation of computerized systems, ensuring compliance with applicable standards and regulations.- Collaboration with IT teams and system vendors to ensure proper implementation and validation of computerized systems.- Analysis and interpretation of data generated during qualification and validation processes, providing insights and recommendations for continuous improvements.- Knowledge of best practices and current trends in equipment qualification and validation of computerized systems in the pharmaceutical industry.

- Serve as the focal point for matters related to Equipment Qualification, including non-conformities, change controls, and others.- Develops and reviews Standard Operating Procedures (SOPs) for the Equipment Qualification department, ensuring compliance with current standards and best market practices.Manages the schedule for Thermal Qualification and oversees the activities of technicians responsible for on-field execution.- Participates in internal audits and regulatory inspections.

- Actively participated in the construction, commissioning, and qualification projects of the Multipurpose Production Center responsible for the production of various pharmaceutical products, including the Coronavac vaccine against Covid-19.- Took part in the construction, commissioning, and qualification projects of the new production plant for the Influenza Vaccine.- Served as a focal point in matters related to Thermal Equipment Qualification, including non-conformities and change controls.- Developed and revised Standard Operating Procedures (SOPs) targeted at the Equipment Qualification Department, aiming to ensure compliance with current regulations and industry best practices.Managed the Thermal Qualification schedule and closely monitored the activities of technicians responsible for on-field execution.- Participated in internal audits and regulatory inspections.

- Participation in the construction, commissioning, and qualification project of the Weighing, Secondary Packaging, Quality Control Laboratory, and Fill & Finish sectors.- Implementation of the Quality Management System through the development of Standard Operating Procedures (SOPs), Quality Manuals, Operational Manuals, Work Instructions, and management of change controls and deviations.- Development of Standard Operating Procedures focused on the Qualification Department, aiming to comply with current regulations and industry best practices.- Management of the Equipment Qualification Schedule.- Preparation of Installation, Operation, and Performance Qualification Protocols for thermal and process equipment.

Main responsibilities:- Reviewing and approving documents related to Quality Assurance, aiming for the application of best operational practices.- Investigating deviations and managing change control.- Participating in internal audits and inspections by regulatory agencies.- Performing Installation and Operation Qualification of equipment and utilities: - Compressed air. - Nitrogen. - Thermal equipment. - Fillers. - Labeling machines. - Performance Qualification of thermal equipment. - Reactors, Transfer Lines, and fillers' SIP (Sterilization in Place). - Autoclave, oven, muffle furnaces, etc.

- Execution of Process Validation activities for cosmetic and pharmaceutical products.- Execution of Equipment Qualification activities (Fillers, Reactors, Cartoners, Climatic Chambers, Unidirectional Flow, and Autoclave).- Development of Standard Operating Procedures for production activities.

- Development, review, and approval of quality system documents (operational procedures, operating manuals, policies, and work instructions) and validation protocols.- Deviation management and change control.- Participation in internal audits and inspections by regulatory bodies.- Qualified Technical Responsible for the Quality Control Laboratory of Medicinal Gases (Oxygen, Nitrogen, Carbon Dioxide, Synthetic Air, and Nitrous Oxide).

- Development and revision of operational procedures and operating manuals in accordance with RDCs (Resolution of the Collegiate Board) No. 32, 69, and 70.- Operational visits to manufacturing plants.