QP - Quality Assurance

Next Generation; Dublin; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

Next Generation in Dublin is seeking a Junior Qualified Person (QP) to join our Quality Assurance team. The role is hybrid (3 days onsite) with ~80% QA and 20% QP activities, offering hands-on training and a clear pathway to develop into a broader QP position.

You will support deviations, CAPAs, batch documentation review, product release, and inspections, ensuring EU GMP/GDP and MIA compliance while collaborating with global sites.

Qualifications

• Degree in Science, Pharmacy or related discipline.
• QP qualified/eligible or junior QP experience.
• Strong pharmaceutical QA experience within a GMP environment.
• Good knowledge of QMS, GMP/GDP and MIA requirements.
• Experience with batch review/release and regulatory audits.
• Strong communication and stakeholder management skills.
• Comfortable combining hands-on QA responsibilities with developing QP duties.

Responsibilities

• Manage and support pharmaceutical QMS activities including deviations, CAPAs and change controls.
• Support QP activities, batch documentation review and product release.
• Maintain compliance with EU GMP/GDP and MIA requirements.
• Provide QA oversight of CMOs and external manufacturing partners.
• Support HPRA inspections, regulatory audits and inspection readiness.
• Support NPI, Quality Agreements and continuous improvement activities.
• Collaborate with global manufacturing sites, affiliates and cross-functional teams.

Skills

QA experience

QMS

Regulatory audits

Stakeholder management

Communication

Education

Degree in Science/Pharmacy or related

Job description

Junior Qualified Person (QP) - Quality Assurance

Location: Dublin - Hybrid (3 days onsite)

Experience: 5+ years

The Opportunity

An opportunity for an experienced Quality Assurance professional with QP eligibility or junior QP experience to join a pharmaceutical Quality team in Dublin.

The role is approximately 80% QA and 20% QP, offering hands-on training and a clear pathway to develop into a broader QP position.

Key Responsibilities

• Manage and support pharmaceutical QMS activities including deviations, CAPAs and change controls.
• Support QP activities, batch documentation review and product release.
• Maintain compliance with EU GMP/GDP and MIA requirements.
• Provide QA oversight of CMOs and external manufacturing partners.
• Support HPRA inspections, regulatory audits and inspection readiness.
• Support NPI, Quality Agreements and continuous improvement activities.
• Collaborate with global manufacturing sites, affiliates and cross-functional teams.

Experience Required

• Degree in Science, Pharmacy or related discipline.
• QP qualified/eligible or junior QP experience.
• Strong pharmaceutical QA experience within a GMP environment.
• Good knowledge of QMS, GMP/GDP and MIA requirements.
• Experience with batch review/release and regulatory audits.
• Strong communication and stakeholder management skills.
• Comfortable combining hands-on QA responsibilities with developing QP duties.