Liaison with Department of Health (Product registrations, Distribution License, etc.) and Health Professionals.
Product Regulatory Assessments.
Pharmacovigilance (Complaints, Adverse Events, Follow-Ups).
Issue/Revise/Approve
Non-Conformances/Investigations
CAPAs
Change Requests
SOPs
Returned Goods Evaluation
Internal Audits – Prepare Schedule, perform audit, prepare report, provide support to auditees for responses/CAPAs
External Audits – Readiness, Audit process, responses/CAPAs
Among others
Requisitos:
Registro de Profesionales (certificación de Registro de la Oficina de Reglamentación y Certificación de profesionales de la Salud)
Certificación de Colegiación vigente (colegio de farmacéuticos)
License registered - Colegio de Farmacéuticos