As Especialista em Assuntos Médicos, you will lead the end-to-end quality governance system ensuring compliance with BcP/GcP regulations and readiness for audits and inspections
Job Summary
As Especialista em Assuntos Médicos, you will lead the end-to-end quality governance system ensuring compliance with BcP/GcP regulations and readiness for audits and inspections.
You will have the opportunity to influence internal stakeholders and suppliers while driving continuous improvements in quality processes and training.
The company fosters an innovative and collaborative environment committed to science and improving patient lives through ongoing research and quality excellence.
Matching Summary
As Especialista em Assuntos Médicos, you will lead the end-to-end quality governance system ensuring compliance with BcP/GcP regulations and readiness for audits and inspections.
Skills & Requirements
Must-have
GcP/BcP quality governance
Audit and inspection management
Risk management and CAPA oversight
GxP system validation
Document control lifecycle
Training development and delivery
Stakeholder and supplier management
Nice-to-have
Advanced Excel for KPI dashboards
Culture of quality and compliance
Collaboration with clinical operations
Data integrity expertise
Change control governance
Key Requirements
Degree in Pharmacy, Nursing, Biomedicine, Medicine or related
Strong experience in GcP/BcP quality and clinical research
Proven track record in audits and inspections
Experience in deviation investigations and CAPA management
Expertise in GxP system validation and document governance