Senior QP Quality Assurance Lead – EU GMP

Next Generation Recruitment; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

Qualified Person (QP) - Quality Assurance in Dublin is seeking an experienced professional to act as European QP, review batch documentation, certify release of medicinal products, and ensure EU GMP compliance.

You will manage the QMS, lead internal audits, support regulatory inspections with HPRA, and drive continuous improvement across quality processes. A BSc (Hons) in Science and 5+ years QA experience are required.

Qualifications

• 5+ years of QA experience in healthcare.
• Strong knowledge of GMP/GDP and regulatory requirements for medicinal products.
• Experience with batch review, certification and release.
• Knowledge of QMS, CAPA, change control, deviations and regulatory compliance.
• Excellent communication and stakeholder management skills.
• Ability to work independently and maintain strong attention to detail.

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.

Skills

QA expertise

Regulatory communication

Attention to detail

Independent work

Education

BSc (Hons) in Science

QP qualification

Tools

QMS system

Job description

Qualified Person (QP) - Quality Assurance in Dublin is seeking an experienced professional to act as European QP, review batch documentation, certify release of medicinal products, and ensure EU GMP compliance.

You will manage the QMS, lead internal audits, support regulatory inspections with HPRA, and drive continuous improvement across quality processes. A BSc (Hons) in Science and 5+ years QA experience are required.