GMP Quality Auditor & Compliance Specialist

Aphex Group; Clonmel; On-site; EUR 55,000 - 70,000; Full time

Job summary

Aphex Group in Ireland's Munster region seeks a Quality Auditor to join Global Development Quality (GDQ). The role focuses on GMP quality assurance activities and supporting licence compliance for IMP.

You will audit data, procedures, facilities and systems, review release documentation, and collaborate across functions to resolve issues, support recalls, and drive continuous improvement while maintaining cGMP standards.

Qualifications

• Degree in an Engineering or Science discipline.
• Significant industrial experience.
• Auditing and quality assurance exposure preferred.

Responsibilities

• Completes audits of data, information, procedures, facilities, equipment and systems to ensure SOP, GMP and regulatory compliance.
• Review and approve production and analytical documentation for release, including QP certification support.
• Collaborate across functions to resolve comments and issues identified during audits and reviews.
• Support product recalls and stock recoveries as appropriate.
• Identify compliance gaps and propose continuous improvement actions.
• Create and maintain assigned SOPs.
• Perform and review complaints and deviation investigations, change controls and CAPAs.
• May assist in induction for new starters; follow standard procedures and consults with manager on exceptions.
• Prepare data for reports and presentations; interpret data and draw conclusions.
• Adhere to cGMP requirements and regulatory standards.

Skills

Auditing

GMP knowledge

Regulatory compliance

Documentation review

Communication

Data interpretation

Education

Engineering or Science degree

Job description

Aphex Group in Ireland's Munster region seeks a Quality Auditor to join Global Development Quality (GDQ). The role focuses on GMP quality assurance activities and supporting licence compliance for IMP.

You will audit data, procedures, facilities and systems, review release documentation, and collaborate across functions to resolve issues, support recalls, and drive continuous improvement while maintaining cGMP standards.