Jorge Iván Carrillo Soto

Pharmaceutical Chemist (QFB) with experience in the implementation and management of Quality Management Systems (QMS) within the pharmaceutical industry. Specialized in document control, CAPA management (deviations, non-conformities and complaints), risk analysis (FMEA), audits and regulatory compliance.

Background in clinical research and pharmacovigilance, focused on ensuring the quality, safety and traceability of pharmaceutical products.

Quality Management System Coordinator - Farmacias Magistrales S.A. de C.V.

(2025-07 - 2026-07)

• Implemented the Quality Management System (QMS) from scratch.
• Developed and standardized the document management system (SOPs and formats).
• Managed CAPA processes (deviations, complaints and non-conformities).
• Performed root cause analysis using structured methodologies (5 Whys).
• Conducted risk management using FMEA.
• Developed and delivered training programs for personnel.
• Participated in supplier selection and evaluation processes.
• Supported internal and external audits, including follow-up of findings.
• Ensured compliance with applicable health and regulatory requirements.

Regulatory Affairs Assistant / Quality Support - HI-TEC MEDICAL

(2024-07 - 2025-03)

• Developed and updated technical documentation.
• Ensured compliance with national and international regulations.
• Supported internal and external audits.
• Monitored operational processes to ensure quality standards.
• Conducted risk management activities.
• Followed up on ISO certifications and Quality Management System processes.

Clinical Research Assistant - Laboratorio de Patogenicidad Bacteriana del Hospital Infantil de México Federico Gómez

(2023-03 - 2024-07)

• Supported clinical research protocol development.
• Performed data transcription and analysis.
• Ensured compliance with quality and safety requirements.
• Applied laboratory techniques for sample processing and analysis.
• Prepared technical reports with study results.
• Conducted pharmacovigilance activities.

Bachelor's Degree - Pharmaceutical Chemistry (QFB) - Universidad Simón Bolívar (2019 - 2024)