Principal QA Auditor – GCP Experience Required
Syneos Health · Buenos Aires
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.
Questions fréquentes
Por que reporta esta oferta?
Postula en 30 segundos
Ingresa tu email para postular. Se creara una cuenta automaticamente.
Al continuar, aceptas nuestras condiciones de uso.
Ya tienes cuenta? Iniciar sesion
Publicado hace 1 mes
Expira en 3 semanas
27 vistas · 0 interested
Aumenta tus posibilidades
Sube tu CV: te propondremos las ofertas que coinciden con tu perfil.
Analizando tu CV...
Syneos Health
Buenos Aires
Ofertas relacionadas
-
Quality and Regulatory Affairs Auditor
transperfect4 Buenos Aires -
Analista de Farmacovigilancia – Buenos Aires
Konecta Buenos Aires -
Técnico de Servicio e Instalaciones para sumarse al equipo de Medify
Esentia Recursos Humanos Buenos Aires -
Analista de Asuntos Regulatorios y Farmacovigilancia
Bausch + Lomb Riyad -
Médico clínico veterinario
Clínica veterinaria Santa María de los Buenos Aires Capital Federal