Líder de Auditorías
Core
Lead internal audit programs and regulatory inspections to ensure GMP compliance and quality integrity at a pharmaceutical manufacturing site.
Role type
Senior Quality Assurance Audit Leader
Builds
Internal audit programs, regulatory inspection responses, and quality documentation for pharmaceutical manufacturing
Domain
Bio-pharmaceuticals / Manufacturing / Quality Assurance
Required skills
GMP, internal audit management, regulatory inspection coordination, CAPA management, quality system administration, pharmaceutical legislation, technical leadership
Preferred skills
Multinational environment experience, experience with COFEPRIS/FDA/EMA inspections, team administration
Technologies
SAP, GCM, OCM, TW, GAM, Microsoft Office Suite
Responsibilities
Coordinate annual internal audit programs, execute and follow up on internal/external quality audits, manage regulatory inspection responses, administer auditor certification, support regulatory affairs with authority communications, promote quality culture
Seniority
Senior, hands-on IC