EU QP & Global Quality Operations Lead

Azurity Pharmaceuticals; Dublin; On-site; EUR 120,000 - 150,000; Full time

Job summary

Azurity Pharmaceuticals Ireland Ltd. seeks a Qualified Person (QP) to lead EU batch release activities and ensure EU GMP/GDP compliance across markets. The role supports global QA operations, audits, and change control, ensuring product quality across markets.

The candidate must meet HPRA criteria, hold a degree in pharmacy, chemistry, or biology, and have 8+ years in pharmaceutical QA, with prior QP/Deputy QP experience preferred. This is an on-site role based in Ireland.

Qualifications

• Must meet HPRA criteria to act as EU QP.
• Degree in pharmacy, chemistry or biology.
• Minimum 8 years in pharmaceutical QA.
• Previous experience as a QP or Deputy QP.
• Experience with HPRA inspections is beneficial.

Responsibilities

• Certify and release commercial and clinical batches in accordance with EU GMP.
• Ensure product compliance with Marketing Authorizations and MIA requirements.
• Host regulatory inspections from HPRA, manage follow-up actions, liaise with EU authorities.
• Engage in EU Quality Management System: deviation & CAPA handling, change control, and risk assessments.
• Support review or conduct GMP/GDP audits of CMOs, 3PLs, and contract labs within the EU.
• Provide QA oversight for CMOs and collaborate with Supply Chain, Regulatory, and Technical Operations.

Skills

QA

Regulatory inspections

Quality systems

Education

Degree in pharmacy, chemistry, or biology

Job description

Azurity Pharmaceuticals Ireland Ltd. seeks a Qualified Person (QP) to lead EU batch release activities and ensure EU GMP/GDP compliance across markets. The role supports global QA operations, audits, and change control, ensuring product quality across markets.

The candidate must meet HPRA criteria, hold a degree in pharmacy, chemistry, or biology, and have 8+ years in pharmaceutical QA, with prior QP/Deputy QP experience preferred. This is an on-site role based in Ireland.