Qualified Person
Summary
The Qualified Person (QP) is responsible for certifying and releasing medicinal product batches in compliance with EU GMP, regulatory requirements, and the Marketing Authorisation. The role ensures patient safety by overseeing batch disposition and providing quality leadership within AbbVie Biologics Ballytivnan, Sligo.
Responsibilities
1. Ensure compliance with EudraLex Volume 4 EU GMP, Annex 16, and Article 47 of Directive /83/EC for batch certification and release.
2. Certify that each batch is manufactured, tested, and checked in accordance with the Product Specification File, Marketing Authorisation, and applicable regulatory requirements.
3. Maintain oversight of GMP compliance for all products manufactured at site.
4. Disposition bulk product as acceptable for release or rejection based on review of manufacturing and testing data to ensure patient safety.
5. Manage day-to-day quality issues arising from operations and escalate significant issues to relevant stakeholders as required.
6. Provide technical quality leadership and support cross-functional teams, continuous improvement initiatives, and cost improvement projects.
7. Collaborate with internal stakeholders and external suppliers to maintain a compliant and efficient quality system.
8. Operate with a high level of autonomy in line with established quality systems, AbbVie ways of working, and EHS requirements.
Requirements
9. Third-level qualification in a scientific discipline with a minimum of five years' experience in the pharmaceutical industry.
10. Postgraduate qualification such as an MSc in Industrial Pharmaceutical Science, or equivalent, recognized by the Regulatory Authority to permit Qualified Person status under Article 49 of Directive /83/EC.
11. A minimum of five years' industrial experience in an FDA- and EMA-approved pharmaceutical manufacturing environment.
12. At least two years' experience in an aseptic processing environment, ideally within a quality function.
13. Strong capability to assess complex quality issues and rapidly develop understanding of products and processes.
14. Excellent interpersonal and communication skills with the ability to work effectively across functions and levels.
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