Auditor - Glp

VacaturesInFarma

Global rdq audit program execution
External clinical investigator site audits
Gxp regulatory compliance knowledge
This role is responsible for executing the global RDQ audit program to ensure accuracy of scientific data and compliance with GxPs

Job Summary

  • This role is responsible for executing the global RDQ audit program to ensure accuracy of scientific data and compliance with GxPs.
  • The position involves performing external audits of clinical sites, databases, and vendors while developing corrective and preventive action plans.
  • CSL Behring is a global biotherapeutics leader committed to saving lives through innovative therapies and a culture of inclusion.

Matching Summary

This role is responsible for executing the global RDQ audit program to ensure accuracy of scientific data and compliance with GxPs.

Skills & Requirements

Must-have

  • Global RDQ audit program execution
  • External clinical investigator site audits
  • GxP regulatory compliance knowledge
  • Audit report drafting and CAPA recommendations
  • Risk-based approach to inspections

Nice-to-have

  • Multinational team collaboration skills
  • Continuous improvement initiative support
  • Strong negotiation and influencing abilities
  • Experience with CROs and vendor audits

Key Requirements

  • BS degree in biological science or related discipline
  • 3+ years of Quality Assurance experience in GVP/GCP environments
  • Demonstrated knowledge of QMS implementation and regulatory frameworks

Work Rights

Not specified

Tailored Resume

Cover Letter