EU QP & Quality Ops Lead - Europe/Intl

Azurity Pharmaceuticals - Ireland; Dublin; Hybrid; EUR 90,000 - 140,000; Full time

Job summary

Azurity Pharmaceuticals Ireland Ltd. seeks a Qualified Person (QP) to lead EU batch release and ensure EU GMP/GDP compliance, while supporting global quality operations including CMO oversight, deviations, CAPA, and audits.

The ideal candidate has HPRA eligibility as EU QP, a degree in pharmacy, chemistry, or biology, and 8+ years in pharmaceutical QA with QP/Deputy QP experience. This hybrid, Dublin-based role offers impactful quality leadership.

Qualifications

• Must meet HPRA criteria to act as EU QP under EU legislation.
• 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 batches in accordance with EU GMP.
• Ensure product compliance with MA and MIA requirements.
• Host regulatory inspections and liaise with EU authorities.
• Support QA deviations, CAPA, and change control processes.
• Assist with audits of CMOs, 3PLs, and contract labs in the EU.
• QA oversight for CMOs and quality audits.

Skills

HPRA criteria knowledge

Quality Assurance

Regulatory inspections

Leadership

Cross-functional collaboration

Education

Degree in pharmacy

Degree in chemistry

Degree in biology

Job description

Azurity Pharmaceuticals Ireland Ltd. seeks a Qualified Person (QP) to lead EU batch release and ensure EU GMP/GDP compliance, while supporting global quality operations including CMO oversight, deviations, CAPA, and audits.

The ideal candidate has HPRA eligibility as EU QP, a degree in pharmacy, chemistry, or biology, and 8+ years in pharmaceutical QA with QP/Deputy QP experience. This hybrid, Dublin-based role offers impactful quality leadership.