Especialista Assuntos Médicos - Qualidade

AstraZeneca

Quality system design and governance
Audits and inspections management
Deviation and capa investigations
You will lead and influence quality governance end-to-end in a dynamic and innovative environment, ensuring compliance with BcP/GcP regulations

Job Summary

  • You will lead and influence quality governance end-to-end in a dynamic and innovative environment, ensuring compliance with BcP/GcP regulations.
  • The role involves designing and maintaining quality systems, conducting audits and inspections, managing risks and CAPAs, and enabling change processes and training.
  • AstraZeneca offers a vibrant environment that encourages new ideas, collaboration, and reinvestment in continuous research to drive real-world change in healthcare.

Matching Summary

You will lead and influence quality governance end-to-end in a dynamic and innovative environment, ensuring compliance with BcP/GcP regulations.

Skills & Requirements

Must-have

  • Quality system design and governance
  • Audits and inspections management
  • Deviation and CAPA investigations
  • GxP system validation and compliance
  • Risk management and mitigation
  • Document control and SOP lifecycle
  • Stakeholder and supplier management

Nice-to-have

  • Training development and delivery
  • Quality culture ambassador
  • Dashboard and KPI monitoring
  • Collaboration with clinical operations
  • Advanced Excel proficiency

Key Requirements

  • 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
  • GxP system validation expertise
  • Advanced English proficiency for audits and documentation

Work Rights

Not specified

Tailored Resume

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