Sr. QA Auditor

Responsibilities

• Review and approve investigations, Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA), and Effectiveness Check (EC) plans.
• Manage and oversee quality event updates within the electronic quality management system (eQMS).
• Evaluate policies and procedures for compliance with applicable regulations and guidelines.
• Provide consultation to internal stakeholders on interpreting audit/inspection observations and formulating CAPA plans.
• Lead and collaborate on QA initiatives and projects aimed at quality and process improvements.
• Assist in the training and onboarding of new Quality Assurance staff.
• Ensure accurate reporting and documentation of robust CAPAs and track them through to closure.

Requirements

• Bachelor's Degree.
• 8+ years of relevant experience in pharmaceutical, technical, or related areas.
• Minimum of 6 years of dedicated experience in Quality Assurance.
• Proven experience working within GXP environments.
• Strong knowledge of Root Cause Analysis (RCA) and CAPA processes.
• Advanced knowledge of QA job functions and related regulatory areas.

About the Company

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.