As Especialista em Assuntos Médicos, you will lead quality governance end-to-end, ensuring compliance with BcP/GcP regulations and readiness for audits and inspections with high autonomy
Job Summary
As Especialista em Assuntos Médicos, you will lead quality governance end-to-end, ensuring compliance with BcP/GcP regulations and readiness for audits and inspections with high autonomy.
You will design and maintain the quality system, conduct risk assessments, manage CAPAs, and enable change processes and training to foster a culture of quality and compliance.
Joining AstraZeneca offers the opportunity to contribute to medical innovation in a vibrant, collaborative environment committed to science and continuous research investment.
Matching Summary
As Especialista em Assuntos Médicos, you will lead quality governance end-to-end, ensuring compliance with BcP/GcP regulations and readiness for audits and inspections with high autonomy.
Skills & Requirements
Must-have
GcP/BcP quality governance
audit and inspection management
risk management and CAPA
GxP system validation
document control and SOP management
training development and delivery
stakeholder and supplier management
Nice-to-have
advanced Excel skills
data integrity culture ambassador
collaborative and innovative environment
Key Requirements
Bachelor's degree in Pharmacy, Nursing, Biomedicine, Medicine or related
Solid experience in GcP/BcP quality and clinical research
Active participation in audits and inspections
Experience with deviation investigations and CAPA management
Advanced English proficiency
Experience with GxP systems like Veeva
Knowledge of regulatory requirements and data integrity guidelines