Quality Assurance Engineer – CAPA III

About the role

The Quality Assurance Engineer – CAPA III will manage the resolution of exception reports linked to AbbVie’s Quality System, including non‑conformance reports (NCRs) and process risk assessments (PRAs). The role ensures compliance with GMP standards and supports audit activities while driving corrective and preventive actions.

Key responsibilities

• Review, approve and document outcomes of exception reports, capturing containment, correction and prevention actions.
• Act as subject‑matter expert in quality system events, leading investigations and defining root‑cause actions.
• Guide NCR and audit processes to meet internal and regulatory requirements.
• Prioritize resources to execute corrective actions and verify their effectiveness within defined metrics.
• Explain exception documentation during internal and external audits.
• Maintain timely compliance with NCR commitments to support site quality metrics.
• Continuously improve Quality System processes and related documentation.
• Ensure adherence to corporate and legal EHS policies and promote EHS initiatives.

Required profile

• Bachelor’s degree in Engineering (Electromechanical, Electrical, Chemistry preferred).
• Intermediate English proficiency (B2+, C1 preferred).
• Minimum 3 years of experience leading CAPA and NCR resolution.

Required skills

• CAPA management
• NCR handling
• GMP compliance
• Root‑cause analysis
• Audit documentation