Ana Merino Méndez

Senior Qualifications and Quality Assurance consultant with over 20 years of experience in QA Systems, Cleaning, Sterilization, Disinfection and Depyrogenation Validation Processes, Process Qualification, Continuous Process Verification, Equipment Qualification, Environmental Monitoring and audits made by international regulatory agencies, such as EMEA, FDA, ANVISA or JP. 

Proven ability to lead teams, cross-functional collaboration with QA, QC, Engineering, and Manufacturing, Project management and team training in validation best practices. Extensive experience in validation across GMP-compliant environments (EU GMP, FDA, ICH Q7/Q9/Q10), covering sterile and non-sterile manufacturing.

Senior Qualifications and Quality Assurance consultant with over 20 years of experience in QA Systems, Cleaning, Sterilization, Disinfection and Depyrogenation Validation Processes, Process Qualification, Continuous Process Verification, Equipment Qualification, Environmental Monitoring and audits made by international regulatory agencies, such as EMEA, FDA, ANVISA or JP. 

Proven ability to lead teams, cross-functional collaboration with QA, QC, Engineering, and Manufacturing, Project management and team training in validation best practices. Extensive experience in validation across GMP-compliant environments (EU GMP, FDA, ICH Q7/Q9/Q10), covering sterile and non-sterile manufacturing.

• Master of Science (M.Sc.) - Regulatory Affairs, CESIF, 2022
• Master of Science (M.Sc.) - Integrated Management Systems with focus on Quality, Occupational Risk Prevention, and Environmental Protection, FME, 2005.
• Master of Science (M.Sc.) – Gas Chromatography and Mass Spectrometry, IUCT, 2004.
• Bachelor of Science (B.Sc.) – Chemistry, Universidad de Salamanca, 2003.