Experience

ROVI Pharmaceutical Company

• Spain
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Coordinador de QA CSV

  • Sep 2022 - Present

  Responsabile del data integrity e della compliance con le norme GMP, GAMP5 e 21CFR.Revisione e coordinamento delle attività di Convalida di Sistemi informatici del reparto di Produzione e dei 4 laboratori aziendali.

• Técnico de validación

  • Aug 2021 - Dec 2022

  Experiencia en auditorías FDA.Experta en cualificación de equipos de producción de medicamentos inyectables, validación de proceso y de Mediafill con evaluación estadística de los resultados obtenidos a través del software Minitab, validación de limpieza, cualificación de HVAC y de utilities. Preparación de documentación de validación/cualificación Gestión de CAPA e investigaciones.



Recipharm

• Sweden
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Validation Technician

  • Sep 2018 - Present

  Responsible of activities of Analytical Method Transfer applied to the new solid oral products. Experience in the whole projects activities, from method transfer protocols preparation, travels to the Development Laboratories for training, coordination of Quality Validation lab team (6 analysts), organization and revision of analytical activities, and finally Analytical Method Transfer reports. Experience in analytical method validation applied to Cleaning Validation and coordination of laboratories activities during Process Validation.Experience in Change Control of Production Department and QC Laboratory as Change Controller.Experience in Qualification activities of Laboratory equipment in compliance with 21 CFR.Implementation of ICH Q3D guideline applied to new and existing products.



Linnea SA

• Switzerland
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Validation Specialist and Process Technologist assistant

  • Sep 2016 - Aug 2018

  Validation Specialist in Quality Assurance department and Process Technologist assistant in Production department.Responsible of ICH Q3D implementation for all products of syntesis.Experience in preparation of SOP and Master Batch Record of Processes and Cleaning, and implementation of new manufacturing processes in collaboration with Process Technologists and Engineering department. Responsible of Cleaning Validation in multipurpose equipment, solvents recovery validation, process validation, and relevant documentation (VMP, QRA, VP, VR, VSR). Experience in Quality Risk Assessment (FMEA technique etc.).Experience in audit by authorities and clients.

• Validation Specialist

  • Sep 2014 - Sep 2016

  Validation specialist (Quality Assurance AND Production departments), excellent knowledge of GMPs and their applications in processes, industrial installations and systems for the production of API. Production SOP, risk analysis, validation protocols preparation, also involved in qualification of equipment.



DragonTT Motors

• Spain
• Design
• 1 - 100 Employee

• Project Coordinator (technical design and materials specialist)

  • May 2013 - Apr 2014

  Plastics and composite materials specialist for production and developement of motorcycle fairingsResponsible of technical design of motorcycle fairings with the design software Rhinoceros Plastics and composite materials specialist for production and developement of motorcycle fairingsResponsible of technical design of motorcycle fairings with the design software Rhinoceros



Firescon Ing. Consultores

• Products, Services and Trainings Responsible

  • Jun 2013 - Dec 2013

  Hydraulic computation for fire protection systems based on water, using calculation software HASS.Responsible of international relationships with customers from UK, USA, Latin America and Italia. Hydraulic computation for fire protection systems based on water, using calculation software HASS.Responsible of international relationships with customers from UK, USA, Latin America and Italia.



Ducati Motor Holding

• Italy
• Motor Vehicle Manufacturing
• 700 & Above Employee

• Internship

  • 2010 - 2010

  Materials Laboratory, in particular analysis of metallic materials, samples preparation, metallographic analysis. Materials Laboratory, in particular analysis of metallic materials, samples preparation, metallographic analysis.