EU QP & Global QA Operations Lead

RXinsider LTD.; Dublin; On-site; EUR 80,000 - 120,000; Full time

Job summary

Azurity Pharmaceuticals Ireland Ltd. is seeking a Qualified Person (QP) to lead EU batch release activities and ensure full EU GMP & GDP compliance. The role supports global QA operations including CMO oversight, deviation, CAPA management, and audits across EU facilities.

Strong regulatory knowledge and prior QP experience are essential. Key duties include hosting HPRA inspections, maintaining MA/MIA alignment, and driving continuous improvement within the EU QA framework while collaborating

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 batches under EU GMP as EU QP.
• Ensure compliance with MA and MIA requirements.
• Host HPRA inspections and manage follow-up actions.
• Engage in QA system activities: deviations, CAPA, change control.
• Support audits of CMOs, 3PLs, and contract labs in the EU.
• Provide training on EU compliance requirements.

Skills

HPRA criteria

QA oversight

Regulatory liaison

Quality audits

GMP/GDP awareness

Education

Degree in pharmacy

Job description

Azurity Pharmaceuticals Ireland Ltd. is seeking a Qualified Person (QP) to lead EU batch release activities and ensure full EU GMP & GDP compliance. The role supports global QA operations including CMO oversight, deviation, CAPA management, and audits across EU facilities.

Strong regulatory knowledge and prior QP experience are essential. Key duties include hosting HPRA inspections, maintaining MA/MIA alignment, and driving continuous improvement within the EU QA framework while collaborating