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Start for FreeLázaro Wandré S. Oliveira
Senior Validation Specialist @Novo Nordisk
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WORK HISTORY
Senior Validation Specialist @Novo Nordisk
US
Serves as site representative and subject matter expert within all areas of validation across site API US. Leads all major validation strategy and implementation across site in close collaboration with line of business and quality. Maintains detailed knowledge of the Novo Nordisk validation procedures/validation manual & directs projects/areas in how to perform validation steps.
EDUCATION
FACET - Faculdades de Ciências Exatas e Tecnológicas Santo Agostinho
Bachelor degree in Electrical Engineering FACET (2010) (Diploma approved by Danish Authorities), Electrical and Electronics Engineering
Professionshøjskolen Absalon
Technology Diploma in Biotechnology, process technology and chemistry , Module General chemistry (physical chemistry)
SKILLS
ABOUT LÁZARO WANDRÉ S. OLIVEIRA
I have more than 14 years experience at Novo Nordisk working on pharmaceutical manufacturing process, qualification, validation and Audit/Inspection/Regulatory interaction.I\'m experienced on equipment qualification to support the ramp-up to commercial production and process performance validation. More specifically, applying specialized knowledge of Science and Risk based Validation processes to plan experiments and define protocols for testing the facility\'s performance. I follow up on the results of these trials to identify deviations and non-conformities; troubleshoot issues in connection with these deviations; and recommend fixes to improve the quality of products in line with Novo Nordisk\'s high-quality standards. I\'ve supported the transfer of knowledge of specialized testing which can only be gained through employment within Novo Nordisk\'s production facilities abroad to the engineers and operations to ensure they understand and adhere to all applicable internal processes, procedures, and guidelines related to the manufacturing process.As a validation expert, I\'ve also tasked with applying specialized knowledge of Novo Nordisk\'s internal protocols for the manufacturing area, cGMP manufacturing guidelines, and project management standards to provide expert input in the site\'s preparation for product launch, including updating these as necessary to conform with global standards. I\'ve reviewed scientific documentation and prepared regular reports for senior management and registration authorities, as necessary. I\'m responsible to ensure coordination and collaboration between project and other site stakeholders while gathering and ensuring key knowledge transfer to the site from the DK sponsor site.I have specialized knowledge of Novo Nordisk\'s equipment and internal validation protocols for the manufacturing area, validation techniques, and project management processes to provide training and guidance to engineering personnel.
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