QP - Quality Assurance

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

Job summary

Next Generation in Dublin is seeking a Senior Qualified Person (QP) to oversee the QMS, ensure EU GMP compliance and certify finished medicinal products.

You will lead regulatory activities, support inspections, coordinate batch release and drive continuous improvement across quality systems.

Qualifications

• BSc (Hons) in Science or equivalent.
• 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.

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

Quality Assurance

Stakeholder management

Communication

Independence

Education

BSc (Hons) in Science

Tools

QMS

CAPA system

Job description

Qualified Person (QP) – Quality Assurance

Location: Dublin

Experience: 5+ years

A senior Quality Assurance opportunity for an experienced Qualified Person to take responsibility for QMS oversight, regulatory compliance and batch certification within a regulated pharmaceutical environment.

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.