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