Itzel Vazquez Ahuatzin

Senior Quality Assurance and Project Manager with 10+ years of experience in the pharmaceutical industry, specialized in Computerized System Validation (CSV), GxP regulatory compliance, and quality oversight of regulated computerized systems. Deep expertise in 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+, and global Health Authority expectations. Proven track record as Quality point of contact between IT and Business, reviewing and approving GxP changes, periodic review reports, deviations, and CAPAs.

Experienced validating, LIMS and ERP. Committed to promoting a Quality Culture and building trusted partnerships with IT functions and operational stakeholders.

Consultant – Digital Health / Medical Device Software (SaMD) at Ancient | BUPA Mexico Project (2025-11 – Present)

• Act as eCompliance reference for digital health and SaMD initiatives, providing quality oversight aligned with COFEPRIS, ISO 13485, GAMP 5, and ICH Q9.
• Review and approve risk-based documentation, validation strategies, and traceability matrices for GxP-relevant digital systems.
• Assess GxP applicability for new computerized systems and digital applications, including cybersecurity considerations for regulated environments.
• Coordinate compliance deliverables across technical, quality, cybersecurity, medical, and information security stakeholders, ensuring regulatory readiness and project execution.

Project Manager – / Computerized System Validation at PQE Group (2024-10 – 2025-09)

• Provided Quality Assurance oversight for CSV projects ensuring compliance with NOM-059, NOM-241, 21 CFR Part 11, GAMP 5, and ALCOA+ data integrity requirements.
• Reviewed and approved GxP changes and associated CSV deliverables (URS, FS, DQIQ/OQ/PQ, RTM, Validation Summary Reports) for pharmaceutical clients.
• Led quality oversight for GxP critical spreadsheets and Laboratory Systems (LAS) validation, including traceability, security controls, and data reliability.
• Supported SAP validation in a regulated environment: contributed to requirement definition, test strategy, and regulatory compliance for GxP-impacted business processes.
• Served as key interface between IT and Quality teams, managing project planning, timelines, and deliverables with global pharmaceutical clients in Mexico.

Specialist Leader – Validation & Qualification / Validation Auditor at ANEN Consultores (2018-06 – 2024-10)

• Provided eCompliance and CSV quality oversight for pharmaceutical and medical device clients; reviewed and approved validation documentation for GxP computerized systems.
• Conducted specialized GxP audits; assessed supplier qualification and provided audit support and CAPA implementation guidance.
• Served as organizational Point of Contact for CSV-related matters, acting as interface between IT, Quality, and Business stakeholders.
• Contributed to Validation Master Plans (VMPs); tracked periodic reviews and managed deviation and CAPA cycles for regulated systems.
• Provided technical support for COFEPRIS inspections; delivered training on risk management, CSV, and GxP compliance to Managers and Supervisors.
• Led turnkey qualification projects for facilities designed in compliance with NOM-249, NOM-241, and NOM-059.

Validation Chemist at Laboratorios Selder S.A. de C.V. (2016-04 – 2018-06)

• Executed qualification protocols (IQ/OQ/PQ) for critical systems, process equipment, facilities, and QC laboratory instruments.
• Developed URS, Design Specifications, and Functional Specifications; maintained validated state documentation.
• Managed CAPAs, change controls, and deviations aligned with FEUM, NOM-059-SSA1-2015, USP, and ISO standards.
• Ensured FDA and COFEPRIS audit readiness; applied GMP and GDP principles throughout lifecycle management.

Project Engineer at Laboratorios de Biologicos y Reactivos de Mexico S.A. de C.V. (2012-12 – 2016-03)

• Verified installation of critical systems; supervised FAT and SAT testing for major equipment and utilities.
• Coordinated startup activities and prepared commissioning protocols; created engineering drawings in AutoCAD.

Executive MBA in Business Administration – Universidad La Salle Mexico (2023 – 2025)

Biotechnology Engineering in Biotechnology Engineering – Instituto Politecnico Nacional (2008 – 2013)

Professional Certification in Project Management – Universidad La Salle Mexico