Qualified Person
AbbVie View all jobs
- Sligo
- Permanent
- Part-time
- 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, efficient relationships and optimized processes
- Ensure compliance with EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice, Annex 16, marketing authorisations, and all regulatory obligations
- Certify that batches are manufactured and checked per legal, GMP, specification, and authorisation requirements
- Oversee batch disposition (release or reject) based on comprehensive manufacturing and testing data
- Maintain review and completion of all necessary production and quality documentation, ensuring records are accurate and endorsed
- Assess and resolve daily quality issues and deviations, maintaining high standards of expertise and attention to detail
- Authorize and evaluate deviations or planned changes, 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
- Foster a culture of safety, EHS excellence, integrity, and continuous improvement within the organization
- Perform other duties as assigned
- Bachelor's degree in a science discipline and 5+ years' experience in an FDA/EMEA pharmaceutical environment
- MSc (or equivalent) meeting QP qualification per Directive 2001/83/EC, Article 49
- 2+ years' aseptic processing experience, preferably in a quality function
- Demonstrated decision-making, problem-solving, and communication skills
- Experience in leading teams and supporting cross-functional groups
- Experience as a QP on a license (preferred); sterile fill-finish manufacturing experience (desirable)
- AbbVie will never request sensitive personal information (such as bank account details, social security numbers, or payment of any kind) during the recruitment process.
- If you suspect you have received a fraudulent offer or communication claiming to be from AbbVie, please do not respond, open any attachments, or click on any hyperlinks.
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