About Esthy
Aprovecho mis 25 años de experiencia global en los sectores farmacéutico y de biotecnología para ayudar a los clientes a optimizar sus procesos de Garantía de Calidad y Control de Calidad y garantizar el cumplimiento normativo. He trabajado con empresas reguladas de primer nivel en Estados Unidos y Europa, dominando regulaciones y normas internacionales como FDA 21 CFR Parte 210-211, 21 CFR Parte 820, EMA, ISO 13485, MDR (UE) 2017/745 y IVD (UE) 2017/746.
Mi experiencia abarca todo el ciclo de vida del producto, desde el diseño y desarrollo hasta validación y fabricación de producto final, en las industrias bio-farmacéutica y de dispositivos médicos. He gestionado y diseñado con éxito Laboratorios de Control de Calidad, equipos de trabajo sobresaliendo en auditorías de calidad, y manejado de inspecciones externas y certificaciones de prestigiosos organismos reguladores y organismos notificados. También he facilitado transferencias de tecnología globales y autorizaciones, lanzamientos y liberaciones de productos en startups de biotecnología y dispositivos médicos.
Spanish
Native or bilingual
Can work on-site
Barcelona (up to 50km), Madrid (up to 50km)
Experience
- BiotechnologyStrategic Consultant and Mentor in Quality and RegulatoryBIOTECHNovember 2022 - Today (3 years and 7 months)SpainSr. Quality Operations & Development Consultant With 20+ years in highly regulated GMP environments, driving regulatory compliance, continious improvements, and operational excellence. Key Responsibilities:• 483 FDA Letter Defense Strategies: Develope meticulous strategies aligning with regulations, ensuring compliance and operational efficiency.• SOP Revision for OOS/OOT: Led SOP revisions for Out-of-Specification/ Trend management, adhering to FDA guidelines and 21 CFR Part 211, enhancing accuracy and compliance.• QC Lab Procedures Optimization: Reviewed and optimized QC lab procedures, aligning with SOPs, regulatory standards, USP, EP and ICH guidelines, ensuring compliance and efficacy.• External Audits and CAPA: Conduct external audits, propose improvements mandated by FDA, EMA, and AEMPS, address non-conformities within the Quality organization, leading investigations and CAPA initiatives.• Specialized Training: Provided training focused on regulatory standards, aiming to enhance knowledge and foster a culture of compliance among teams.• As the Technical Director of Medical Devices Importers, ensure compliance with MDR, AEMPS regulations and standards, and managed Manufacturing Facilities Licenses, facilitating inspections and documentation submissions. In summary, my consultancy focuses on regulatory compliance, process optimization, and comprehensive training. With extensive experience in Biotech Quality, I enhance operational efficiency and regulatory adherence in biotech and biopharma sectors.
- The Binding SiteRegulatory Affairs Project ManagerBIOTECHApril 2021 - October 2022 (1 year and 6 months)Barcelona, SpainManage regulatory aspects of new product developments (NPD) throughout product design life cycle. Responsible for the generation of STED Files under the new IVD Regulation EU 2017/746 and ISO13485 for the BS pipeline. Elaborate and manage RA Strategy and Plans for global markets, Q-subs,510k submissions documentation, lead the submissions and review process with applicable notified bodies. Identify areas of improvement and implement new processes. Support internal and global audits for ISO13485 and MDSAP Certifications. Support Post Market Surveillance and notifications to notified bodies in applicable countries.
- University of Navarra - CompanyVisiting ProfessorEDUCATION AND E-LEARNINGJanuary 2014 - February 2017 (3 years and 1 month)Pamplona, Navarre, SpainCourse: Quality Control in the Biotech and Pharma industries under cGMP offered in an annual basis in the Department of Pharmacy / Master of R&D and Drug Innovation at the University of Navarra.
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Education
- Master of ChemistryStevens Institute of Technology, New Jersey2003
- Licenciatura en QuímicaUniversidad de Puerto Rico1996