María García Castillo

María García Castillo Email and Phone Number

Head of production and Regulatory affairs at EquiCord @ EquiCord - Stem Cell Bank
madrid, madrid, spain
María García Castillo's Location
Greater Madrid Metropolitan Area, Spain
About María García Castillo

Biologist with wide experience in pharmaceutical industry. In my career, I highlight my role as Production Manager, in which I have coordinated the department staff and the manufacturing activities and validations of cell based-products.In parallel to these functions, as part of the Department of Regulatory Affairs, I have designed the manufacturing process to guarantee the quality standards, authored CMC documentation and defended the approval of cell-based products in meetings with international Authorities (EMA).Such experience in manufacturing and regulatory together with my background in preclinica area result in a polyfacetical profile with a global view of the medicament development.

María García Castillo's Current Company Details
EquiCord - Stem Cell Bank

Equicord - Stem Cell Bank

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Head of production and Regulatory affairs at EquiCord
madrid, madrid, spain
Website:
equicord.com
Employees:
9
María García Castillo Work Experience Details
  • Equicord - Stem Cell Bank
    Head Of Production And Qa-Regulatory Associate
    Equicord - Stem Cell Bank Oct 2014 - Present
    Tres Cantos, Madrid
    * Develop and implement manufacturing process and quality controls of cell-based product as well as Aseptic Process Simulation (APS) in compliance with cGMP and EMA guidelines. * Prepare planification and production orders based on the manufacturing needs.* Plan and coordinate daily operations and production team, ensuring accuracy and time manufacturing of cell-based products.* Develop and implement a personnel training plan for conducting aseptic production activities and manufacturing of cell-based products in clean room.* Organize and review the manufacturing documentation for approval of the batch. * Author and review GMP documentation, including SOPs, manufacturing / stability validation protocols and reports, change controls and risk management plans.* Solve incidences, investigate deviations and establish CAPAs.* Author Chemistry Manufacturing Control (CMC) documentation for regulatory submission by centralize procedure (EMA) and prepare response to deficiency letters.* Take part in meetings with regulatory authorities (EMA) to defend the approval of cell-based medicaments. * Participate in internal audits and support Regulatory inspections (Health authorities) with Quality Assurance to defend the quality system.
  • Vivotecnia
    Study Director
    Vivotecnia 2008 - 2013
    *Organize and supervise in vitro and in vivo pre-clinical studies under Good Laboratory Practices (GLPs) according to the requirements of the European Directive and the Spanish law*Write study plans and reports in English as well as data analysis *Write and implement Standard Operation Procedures*Culture of cell lines and carry out cytotoxicity assays by means of colorimetric methods using tetrazolium salt derivates such as CCK-8, MTT and crystal violet*Perform Western blot and PCR techniques

María García Castillo Skills

Microsoft Office Aptitudes De Laboratorio In Vitro Gmp Desarrollo De Productos Trabajo En Equipo Procedimientos Normalizados De Trabajo Normativa Cmc Estudios De Estabilidad Validaciones

María García Castillo Education Details

Frequently Asked Questions about María García Castillo

What company does María García Castillo work for?

María García Castillo works for Equicord - Stem Cell Bank

What is María García Castillo's role at the current company?

María García Castillo's current role is Head of production and Regulatory affairs at EquiCord.

What schools did María García Castillo attend?

María García Castillo attended Universidad De Alcalá, Universidad Autónoma De Madrid.

What skills is María García Castillo known for?

María García Castillo has skills like Microsoft Office, Aptitudes De Laboratorio, In Vitro, Gmp, Desarrollo De Productos, Trabajo En Equipo, Procedimientos Normalizados De Trabajo, Normativa, Cmc, Estudios De Estabilidad, Validaciones.

Who are María García Castillo's colleagues?

María García Castillo's colleagues are Almudena Pradera, Lucas Oraa Arbeo, Minerva Del Pozo Gómez, Eva Punzón Fernández, Carlota Fernández-Pacheco Martorell, Alicia Rico García.

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