Experience

EquiCord - Stem Cell Bank

• Head of Production and QA-Regulatory Associate

  • 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



Vivotecnia

• Spain
• Research Services
• 1 - 100 Employee

• Study Director

  • 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