Vanessa Andrade
About Vanessa Andrade
Vanessa Andrade is a Quality Technician II at Boston Scientific with over 10 years of experience in pharmaceutical and technology regulatory affairs. She has a background in hospital pharmacy and holds a Master's degree in Pharmaceutical Technology Regulatory Affairs.
Current Position at Boston Scientific
Vanessa Andrade currently holds the position of Quality Technician II at Boston Scientific. In this role, she has been instrumental in developing a customer-focused quality culture by implementing data collection, process monitoring, root cause analysis, and corrective actions. She also facilitates the training of operators on quality procedures and instructions to ensure compliance with quality standards. Additionally, Vanessa conducts internal quality product and process audits covering safety, GMP, quality, and performance.
Previous Experience in Pharmaceutical Supervision
Before her current role, Vanessa worked as a Hospital Pharmacy Supervisor at Hospital Evangelico Da Bahia from 2017 to 2018 in Salvador e Região, Brasil. During her tenure, she was responsible for overseeing pharmacy operations, managing medication inventories, and ensuring strict adherence to pharmaceutical standards. Her role also included supervising pharmacy staff and coordinating with other healthcare professionals to deliver optimal pharmaceutical care.
Educational Background in Pharmaceutical and Regulatory Affairs
Vanessa has a comprehensive educational background in pharmaceutical sciences and regulatory affairs. She obtained a Bachelor of Pharmacy (BPharm) from Faculdade de Tecnologia e Ciências, where she studied from 2004 to 2009. She further advanced her expertise by earning a Master of Science (MS) in Pharmaceutical Technology Regulatory Affairs from South East Technological University in 2022. Additionally, Vanessa has a Certificate in Medical Device Regulatory Affairs from Instituto Racine and a Certificate in English from Atlantic Language Galway.
Regulatory and Quality Management Expertise
With over 10 years of experience in pharmaceutical and technology regulatory affairs, Vanessa has gained extensive expertise in areas such as Advanced EUDRALEX, market authorisations, CTD, FDA, HPRA, and EMA regulations and applications. Her background includes significant experience as a licensed hospital pharmacist, during which she managed internal and external audits, quality management, supplier qualification, and supply chain management. She ensures regulatory compliance with cGMP for organizations like FDA, EMA, and TUV.
Process Improvement and Quality Metrics
In her role at Boston Scientific, Vanessa plays a key role in tracking and analyzing quality metrics to improve decision-making and create plans for process improvement, including cost-saving measures. She actively partners with design, manufacturing, and quality sectors to resolve quality issues and update quality production documents and manufacturing process instructions. Vanessa also hosts meetings with line support teams to discuss process improvement initiatives and principles of lean management.