María García Castillo
Head of Production and QA-Regulatory Associate at EquiCord - Stem Cell Bank- Claim this Profile
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Bio
Experience
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Head of Production and QA-Regulatory Associate
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Oct 2014 - Present
* 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. Show less
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Vivotecnia
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Spain
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Research Services
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1 - 100 Employee
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Study Director
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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 Show less
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Education
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Universidad de Alcalá
Biología -
Universidad Autónoma de Madrid
Biología, Ciencias experimentales