technical experts
Click on our profiles to learn more about us.
GENERAL DIRECTOR
Founder of the company, expert in Process Engineering and Quality Systems. Certified as an instructor and consultant, with a Master’s degree in Engineering and Project Management. She has worked at Roche, BD, Bayer Mexico, and MSD.
PROJECT DIRECTOR
Expert in process validation, project control, cleaning validation, computerized systems validation, and technology transfer. Holds a Master’s degree in Industrial Administration, with professional experience in companies such as Roche Mexico, Bayer Mexico, and Boehringer Ingelheim.
QUALITY/PROJECT LEADER
Manager of the risk management system and regulatory inspection oversight. Expert in equipment qualification and critical systems validation. Holds a Master’s degree in Business Administration and Innovation. Professional experience includes roles at Signa, Merck, Roche, Glaxo, and Bayer.
VALIDATION/PROJECT LEADER
Expert in process validation, cleaning, equipment and critical systems qualification, and quality. Black Belt (Six Sigma). Professional experience includes roles at Farmacéuticos RAYERE, MSD (Valid Pro), and Grupo SOMAR.
MAINTENANCE AND ENGINEERING EXPERT
Maintenance Specialist: Expertise in preventive and predictive maintenance programs, machinery upgrades, and KPI implementation. Skilled in plant engineering, equipment selection, and transfer. Proficient in ISO 9001, HACCP, and GMP. Professional experience includes roles at BIMBO, Mondelez, General Mills, Merck, and more.
SUPPLY CHAIN EXPERT
Expert in Demand and Production Planning. Skilled in warehouse and inventory management, distribution logistics, and S&OP processes, among others. Holds a Master’s degree in Administration and is certified in Green Belt, Six Sigma-Lean Manufacturing. Professional experience includes roles at Laboratorios Sanfer, Bayer Mexico, Stein Corp. (Costa Rica), Neolpharma, and PharmaTycsa.
EXPERT IN PHYSICOCHEMICAL LABORATORIES
Skilled in the development, validation, and transfer of analytical methods for product release and cleaning validation. Experienced in qualifying inspectors for visual methods and sampling. Professional background includes roles at Signa-Apotex, Roche Mexico, and Lakeside.
EXPERT IN PERSONAL GROWTH & ORGANIZATIONAL DEVELOPMENT
Expert in managing anxiety, stress, and emotional imbalance, with 25 years dedicated to personal growth and organizational development. Certified mindfulness trainer, founder, and General Director of the Center for Specialization and Psychological Care AC. Also a professor and keynote speaker.
EXPERT IN MANUFACTURING AND ENGINEERING
Specialist in operations, lean manufacturing, transfers, projects, audits, and quality systems. Certified Green Belt in Lean Six Sigma, Quality Auditor, and ISO 13485 Internal Auditing. Professional experience includes roles at Bayer Mexico, Kimberly Clark, Covidien, and Danaher.
QUALITY/PROJECT LEADER
Administrator of the Risk Management System and Regulatory Inspection Oversight. Expert in equipment qualification and critical systems validation. Holds a Master’s degree in Administration and Business Innovation. Professional experience includes roles at Signa, Merck, Roche, Glaxo, and Bayer.
QBP. MARÍA OLVERA
EXPERT IN MICROBIOLOGY AND QUALITY SYSTEMS
Expert in quality control and quality assurance. Specialized in quality systems, product review, equipment qualification, and process validation. Skilled in Lean Manufacturing continuous improvement and plant decommissioning. Proficient in microbiological and physicochemical analysis, analytical support, and analytical method management. Certified ISO 9000 and 14000 auditor. Professional experience includes roles at Hoechst, Grupo Roussel, Lepetit, Ofimex, Sanofi, and Sanofi Aventis.
FDA INSPECTIONS AND AUDITS
Expert in planning and leading technical and regulatory investigations of pharmaceutical manufacturing facilities. Former FDA Investigator and Compliance Officer in Mexico, and member of the Pharmaceutical Application Manufacturing Fraud Investigation Team. Extensive experience in GMP compliance and pharmaceutical export regulations.
EXPERT ACCREDITED EVALUATOR, VERIFIER, INSPECTION UNIT, AUDITOR
Advisor in the pharmaceutical industry and testing laboratories, expert in diagnostic verification and risk analysis for health supplies and food. Has collaborated with COFEPRIS, the Ministry of Health, CONAGUA, IMTA, and the Undersecretariat for Environmental Improvement.
EXPERT IN MANUFACTURING AND ENGINEERING
Specialist in operations, lean manufacturing, transfers, projects, audits, and quality systems. Certified Green Belt in Lean Six Sigma, Quality Auditor, and ISO 13485 Internal Auditing. Professional experience includes roles at Bayer Mexico, Kimberly Clark, Covidien, and Danaher.
EXPERT IN APPLIED STATISTICS, RISK MANAGEMENT, AND GMP´S.
Expert in applied statistics, GMPs, and risk management in the regulated industry. Senior Member of ASQ and part of the statistics committee at FEUM. Has worked with Baxter, Rorer, Merck, Pfizer, Abbott, and many others. Instructor at Tecnológico de Monterrey for various diploma programs.
HUMAN SYSTEMS EXPERT
Expert in continuous improvement, operational excellence, and human error reduction. Skilled in human capital management, industrial safety, and leadership development. Certified Black Belt in Lean Six Sigma with experience in companies such as General Motors, Syntex, and Roche. Instructor at UAEMex.
HUMAN SYSTEMS EXPERT
Expert in continuous improvement, operational excellence, and human error reduction. Skilled in human capital management, industrial safety, and leadership development. Certified Black Belt in Lean Six Sigma with experience in companies such as General Motors, Syntex, and Roche. Instructor at UAEMex.
PROJECT MANAGEMENT EXPERT
Specialist in chemical processes, fluid flow, pharmaceutical processes, project management, and construction management. Project Management Professional certified by PMI and a member of ISPE. Experience in companies such as Bayer Mexico, CRYOINFRA, and SICAUT.
