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Principal QA Auditor – GCP Experience Required

Syneos Health · Buenos Aires

🇬🇧 English
GCP

Descripcion del puesto

About the role

We are seeking a Principal QA Auditor with extensive Good Clinical Practice (GCP) experience to lead audit activities across our life‑science projects. The role involves planning, executing and reporting on internal, customer and regulatory audits, ensuring compliance with all applicable standards.

Key responsibilities

  • Plan, conduct and lead assigned audits, including “For Cause” investigations.
  • Host and support customer audits and regulatory authority inspections in line with QA SOPs and work instructions.
  • Prepare clear audit reports, communicate findings to auditees and management, and review corrective action responses.
  • Mentor junior QA staff, deliver training on audit processes and regulatory requirements.
  • Develop, review and update QA and regulatory standards, SOPs and work instructions.
  • Serve as Lead Auditor on team‑based audits and represent the organization in external engagements.

Required profile

  • Significant experience in conducting GCP‑based audits within the life‑science or clinical research sector.
  • Strong knowledge of QA SOPs, work instructions, and regulatory inspection processes.
  • Proven ability to produce comprehensive audit reports and manage corrective actions.
  • Experience mentoring and training QA personnel.

Required skills

  • Good Clinical Practice (GCP) compliance.
  • Audit methodology and execution.
  • Regulatory compliance and inspection readiness.

What we offer

  • Opportunity to work with a global leader in life‑science services.
  • Career development and progression within a collaborative environment.
  • Inclusive culture with total rewards and peer‑recognition programs.

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Publicado hace 1 mes

Expira en 3 semanas

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Syneos Health

Buenos Aires