EU QP & Quality Operations Lead

Azurity Pharmaceuticals; Dublin; On-site; EUR 90,000 - 150,000; Full time

Job summary

Azurity Pharmaceuticals Ireland Ltd. is seeking a Qualified Person (QP) to lead EU batch release activities and ensure EU GMP/GDP compliance. The role supports global QA operations, including CMO oversight, deviations, CAPA, change control, audits, and technical batch release.

Applicants should hold a degree in pharmacy, chemistry, or biology, have a minimum of 8 years in pharmaceutical QA, and preferably experience as a QP or Deputy QP, with HPRA inspection exposure seen as advantageous.

Qualifications

• Must meet HPRA criteria to act as EU QP under EU legislation.
• Degree in pharmacy, chemistry, or biology required.
• Minimum 8 years in pharmaceutical QA.
• Experience as QP or Deputy QP preferred; HPRA inspections beneficial.

Responsibilities

• Certify and release commercial and clinical batches in EU GMP compliance.
• Ensure product compliance with Marketing Authorisations and MIA requirements.
• Host HPRA inspections and liaise with EU authorities as needed.
• Support EU QA system: deviations, CAPA, change control and risk assessments.
• Contribute to audits of CMOs, 3PLs, and contract labs within the EU.

Skills

EU QP experience

Quality Assurance

Regulatory compliance

GMP/GDP knowledge

Education

Degree in pharmacy, chemistry or biology

HPRA experience beneficial

Job description

Azurity Pharmaceuticals Ireland Ltd. is seeking a Qualified Person (QP) to lead EU batch release activities and ensure EU GMP/GDP compliance. The role supports global QA operations, including CMO oversight, deviations, CAPA, change control, audits, and technical batch release.

Applicants should hold a degree in pharmacy, chemistry, or biology, have a minimum of 8 years in pharmaceutical QA, and preferably experience as a QP or Deputy QP, with HPRA inspection exposure seen as advantageous.