Senior CAPA & Quality Auditor - GCP Expert

Firstrand Bank India; South Africa; Sur place; ZAR 900 000 - 1 800 000; Plein temps

Résumé du poste

IQVIA is seeking a Senior Quality Auditor to lead CAPA management and QA oversight across GCP-regulated clinical trials. You will assess investigations, ensure root cause analysis, and implement preventative actions while aligning with global regulations and sponsor agreements.

In this senior role, you will train and mentor the CAPA team, oversee audit responses, and drive continuous improvement in quality processes within IQVIA's clinical research framework.

Qualifications

• Extensive experience in GCP Quality Assurance within clinical trials.
• Experience with CAPA management and ICH-GCP guidelines.
• Auditing and inspection support within a GCP-regulated environment.
• Hands-on root cause analyses and quality investigations under GCP.
• Proven ability to train, mentor, and advise stakeholders on GCP quality.

Responsabilités

• Lead and mentor CAPA management activities for complex QIs and audits.
• Collaborate with cross-functional teams to ensure CAPA and quality processes meet regulations.
• Ensure proper documentation of CAPAs in the eQMS and track corrective actions.
• Identify risks and drive continuous process improvements within CAPA systems.
• Advise QA management on audits and system readiness for inspections.
• Develop/generate training on RCA, CAPA, and compliant documentation.

Connaissances

GCP Quality Assurance

CAPA Management

Audit Management

Root Cause Analysis

Training & Mentoring

Formation

Bachelor's Degree in Life Sciences or related field

Outils

eQMS

Description du poste

IQVIA is seeking a Senior Quality Auditor to lead CAPA management and QA oversight across GCP-regulated clinical trials. You will assess investigations, ensure root cause analysis, and implement preventative actions while aligning with global regulations and sponsor agreements.

In this senior role, you will train and mentor the CAPA team, oversee audit responses, and drive continuous improvement in quality processes within IQVIA's clinical research framework.