Especialista Assuntos Médicos - Qualidade

AstraZeneca

Gcp/bcp quality governance
Quality system design and maintenance
Risk management and capa
As a Medical Affairs Specialist, you will be the technical reference in Quality Assurance for BcP/GcP, leading end-to-end quality governance

Job Summary

  • As a Medical Affairs Specialist, you will be the technical reference in Quality Assurance for BcP/GcP, leading end-to-end quality governance.
  • Your mission will be to design and maintain the quality system, conduct audits and inspections, manage risks and strategic CAPAs, as well as enable change and training processes.
  • You will have the opportunity to influence internal stakeholders and suppliers, ensuring adherence to applicable regulations and sustaining readiness for audits and inspections with a high degree of autonomy.

Matching Summary

As a Medical Affairs Specialist, you will be the technical reference in Quality Assurance for BcP/GcP, leading end-to-end quality governance.

Skills & Requirements

Must-have

  • GcP/BcP quality governance
  • Quality system design and maintenance
  • Risk management and CAPA
  • GxP system validation
  • Internal and external audits

Nice-to-have

  • Data integrity culture
  • Stakeholder influence
  • Continuous improvement mindset

Key Requirements

  • Higher education in Pharmacy, Nursing, Biomedicine, Medicine or related
  • Solid experience in Quality with GcP/BcP focus
  • Experience in deviation investigations and CAPAs
  • Experience in GxP system validation
  • Advanced English for audits and documentation

Work Rights

Not specified

Tailored Resume

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