Senior Quality Auditor – CAPA Centre of Excellence

About the role

The Senior Quality Auditor will lead and support corrective and preventive action (CAPA) management for complex quality issues and audit responses. You will mentor a team, ensure compliance with GCP guidelines, and drive continuous improvement across the organization.

Key responsibilities

• Lead and mentor the CAPA management team, fostering a culture of compliance and improvement.
• Oversee CAPA activities for high‑impact quality issues, sponsor audits, and inspections, ensuring root cause analysis and effective corrective actions.
• Collaborate with cross‑functional stakeholders to identify gaps, implement quality processes, and maintain inspection readiness.
• Document and track CAPAs in the electronic Quality Management System (eQMS) and verify effectiveness within required timelines.
• Develop training, guidance, and standard operating procedures for RCA, CAPA execution, and good documentation practices.
• Support internal and external audits, providing expertise on system audit needs and ensuring readiness at all times.

Required profile

• Bachelor’s degree.
• Minimum 7 years of Quality Assurance experience in pharmaceutical or clinical‑trial environments.
• Extensive knowledge of CAPA management, GCP guidelines, and relevant regulatory requirements.
• Proven ability to manage complex quality issues independently.
• Experience in audit and inspection support, root cause analysis, and driving CAPAs to closure.

Required skills

• CAPA Management
• Root Cause Analysis (RCA)
• Good Clinical Practice (GCP) guidelines
• Electronic Quality Management System (eQMS)