Quality Auditor

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

The Quality Auditor is a member of a team within Global Development Quality (GDQ) and is involved in supporting the GMP Quality Assurance activities for the GDQ IMP Licence

Responsibilities

• Completes audits of data, information, procedures, facilities, equipment and systems (inc computer systems) to ensure compliance to SOPs, GMPs and applicable regulations.
• Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
• Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review.
• Support product recalls and stock recoveries as appropriate.
• Identify compliance gaps and make recommendations for continuous improvement
• Creates and maintains assigned SOPs.
• Perform and review complaints and deviation investigations, change controls and CAPA's.
• May assist in the induction process for new starters.
• Generally follows standard procedures and consults with manager/supervisor on exceptions.
• Compiles data for reports and presentations - May interpret data and draw conclusions.
• Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements.
• Keep abreast of cGMP requirements as described in applicable worldwide regulations
• Additional activities may be assigned by the manager/supervisor

Requirements

• Degree in an Engineering or Science discipline.
• Must possess significant industrial experience.