Quality Auditor

Aphex Group; Clonmel; On-site; EUR 45,000 - 60,000; Full time

Job summary

Aphex Group is seeking a Quality Auditor to support Global Development Quality (GDQ) GMP QA activities. You will conduct audits of data, procedures, facilities and systems to ensure SOP and GMP compliance, review release documentation, and collaborate across functions to resolve issues.

The role involves supporting recalls, identifying compliance gaps and maintaining SOPs, with exposure to CAPA investigations and change controls.

Qualifications

• Degree in an Engineering or Science discipline.
• Significant industrial experience.

Responsibilities

• Completes audits of data, information, procedures, facilities, equipment and systems to ensure GMP and SOP compliance.
• Review and approve production and analytical documentation for release of drug substances, products and finished goods for conformance to SOPs, GMP and regulatory requirements.
• Actively collaborate with functional areas to 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 CAPAs.
• 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 assignments to standards of compliance, efficiency, accuracy and safety in line with requirements.
• Keep abreast of cGMP requirements as described in applicable worldwide regulations.

Education

Degree in Engineering or Science discipline

Job description

Purpose

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.