EU Qualified Person & Quality Operations Lead

Azurity Pharmaceuticals - India; Dublin; Hybrid; EUR 90,000 - 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 and GDP compliance.

The role includes supporting global QA operations, CMO oversight, CAPA management, change control, and audits across EU, with focus on regulatory inspections and continuous quality improvements. The successful candidate will have a pharmacy, chemistry, or biology degree, at least 8 years in pharmaceutical QA, and prior QP or Deputy QP experience,

Qualifications

• Must meet the 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 commercial and clinical batches per EU GMP/EC.
• Ensure product compliance with Marketing Authorisations and MIA requirements.
• Host HPRA regulatory inspections and liaison with EU authorities.
• Engage in EU Quality Management System activities: deviation, CAPA, change control, risk assessments.
• Support GMP/GDP audits of CMOs, 3PLs, and contract labs in the EU.
• Support training of QA personnel on EU compliance.

Skills

Regulatory compliance

Quality assurance

GMP/GDP experience

EU QP knowledge

Education

Degree in pharmacy, chemistry, or biology

Minimum 8 years in pharmaceutical QA

Tools

HPRA inspections

Job description

Azurity Pharmaceuticals Ireland Ltd. is seeking a Qualified Person (QP) to lead EU batch release activities and ensure full EU GMP and GDP compliance.

The role includes supporting global QA operations, CMO oversight, CAPA management, change control, and audits across EU, with focus on regulatory inspections and continuous quality improvements. The successful candidate will have a pharmacy, chemistry, or biology degree, at least 8 years in pharmaceutical QA, and prior QP or Deputy QP experience,