QP - Quality Assurance

Qualified Person (QP) - Quality Assurance

Location: Dublin

Experience: 5+ years

Key Responsibilities

• Manage and continuously improve the Quality Management System (QMS).
• Act as a European Qualified Person (QP), ensuring products meet EU GMP and Marketing Authorisation requirements.
• Review batch documentation and certify/release finished medicinal products.
• Provide QA oversight and expertise for New Product Introductions (NPI).
• Manage deviations/non-conformances, CAPAs, change controls, complaints and Quality issues through closure.
• Support regulatory inspections and act as a key Quality contact with the HPRA.
• Maintain Quality processes supporting WDA, MIA and MAH responsibilities.
• Lead/support internal audits, self-inspections and ongoing regulatory compliance activities.
• Review and maintain Quality/Technical Agreements with third-party partners.
• Participate in Quality Management Reviews and drive continuous improvement across the QMS.

Experience Required

• BSc (Hons) in Science or equivalent.
• Qualified Person (QP) qualification with eligibility to act as a European QP.
• 5+ years' Quality Assurance experience within the healthcare industry.
• Strong working knowledge of GMP/GDP and regulatory requirements for medicinal products.
• Experience with batch review, certification and release.
• Strong knowledge of QMS, CAPA, change control, deviations and regulatory compliance.
• Excellent communication, influencing and stakeholder management skills.
• Ability to work independently, prioritise effectively and maintain strong attention to detail.