Qualified Person
- Sligo
- Permanent
- Full-time
- Ensure compliance with EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice and Annex 16 requirements.
- Certify that each batch is manufactured and checked according to relevant laws, GMPs, and product specifications at AbbVie Biologics Ballytivnan Sligo.
- Oversee the disposition of bulk products, determining release or rejection based on manufacturing and testing data.
- Assess and resolve day-to-day quality issues, ensuring products meet quality and safety standards.
- Support cross-functional teams in process improvement and cost efficiency initiatives.
- Provide technical leadership and collaborate with stakeholders to enhance product quality and process optimization.
- Make informed decisions within quality systems, adhering to regulatory standards, and handle quality queries from the operations team.
- Promote a culture of excellence in quality and compliance throughout the organization.
- Participate in internal and external audits, ensuring readiness and compliance with quality standards.
- Essential: Bachelor's degree in a science discipline and a minimum of 5 years of experience in the pharmaceutical industry.
- MSc in Industrial Pharmaceutical Science or equivalent recognized for QP status under Directive 2001/83/EC, Article 49.
- Experience as a QP on a license preferrable
- Experience in aseptic processing and quality functions.