Silvia Calatrava
Silvia is a Pharmacist with more than 25 years of experience in the pharmaceutical sector.
As a consultant she has extensive experience in quality management systems, having implemented and maintained different Health Science related quality systems.
Expert in the development of quality indicators, APQR, supplier evaluation, CAPA, and Change Control management or risk management among other quality tools and eGMP requirements.
Silvia is an international auditor of suppliers including API’s, Contract manufacturing, Third party logistics, transportation, analytical services or sterilization suppliers, as well as facilitates the service of pre-evaluation to the European GMP or GDP certification by national and/or international authorities.
Her best business card is to ensure that the Company achieves a Quality Management System that, while complying at all times with the regulations, is simple, agile, intuitive, but always robust and documented.
This experience is backed up by her experience in different positions of responsibility such as Quality Assurance Director, Qualified Person or Responsible Person among other in several companies.
She is currently a founding partner of Afiplus Consultores and collaborates with MGA Business Consulting, S.L., developing her professional activity as a Senior Consultant in Quality Management.