Qualified Person

AbbVie is hiring a Qualified Person to join their site in Ballytivanan, Sligo, Ireland. The QP ensures pharmaceutical product quality, safety, and regulatory compliance.

Requirements

• Provide technical leadership and guidance to functional areas
• Lead teams of up to 6 people and support cross-functional teams and projects
• Collaborate with suppliers and internal/external stakeholders to maintain compliant relationships and optimized processes
• Ensure compliance with EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice
• Certify batches are manufactured and checked per legal, GMP, specification, and authorisation requirements
• Oversee batch disposition and maintain review and completion of production and quality documentation
• Assess and resolve daily quality issues and deviations
• Authorize and evaluate deviations or planned changes and participate in notification processes with regulatory authorities
• Ensure principal manufacturing and testing processes are validated, audit readiness maintained, and improvements driven
• Initiate and oversee additional sampling, inspection, tests, or checks as needed due to deviations or changes
• Continuously develop technical/scientific knowledge and expertise for existing and new product types

Benefits

• Comprehensive benefits package
• Opportunities for career growth and development
• Collaborative and dynamic work environment
• Competitive salary and bonus structure