Roberto R.

• I am a Senior Quality Specialist, CQSC, at Alexion Pharmaceutical/AstraZeneca Rare Diseases’ – Global Audit & HA Inspections (GMP & GDP), responsible for managing Audits with a vast portfolio working with several clients worldwide. I intend to expand my skills and knowledge in Global Audit & HA Inspections (GMP & GDP) Central Quality Systems & Compliance (CQSC) segment. I also have served as a Compliance Officer (CAPA Management) on an extensive GCP & GVP audit portfolio, managing, following up and driving CAPAs (Critical, Major and Minor Observations/Findings) to their closeout following the current legislation working along with many third-party sites worldwide where I could improve my active listening, empathy, leadership, and teamwork skills. • I have also acted as a Pharmacovigilance Specialist on a comprehensive portfolio of work involving numerous clinical trials and post-marketing studies across various indications providing regulatory advice and support to internal and external customers from development through full life cycle management. • Experience in the GCP-GVP and regulatory reporting subject with demonstrated knowledge of scientific principles, e.g., R&D, Quality, and Clinical Research. • Client-focused approach with attention to detail, strong organizational skills, and prioritizing multiple projects. Languages: Portuguese – Mother Language | English – Full professional proficiency.