GMP Quality Auditor – CAPA & Compliance Expert

PE Global; Munster; On-site; EUR 55,000 - 75,000; Part time

Job summary

PE Global is seeking a Quality Auditor for a leading pharmaceutical company in Tipperary, Ireland. This 11‑month contract role sits within Global Development Quality (GDQ) and supports GMP QA activities for the GDQ IMP Licence at the site.

The role involves auditing data and systems, reviewing release documentation, and collaborating with cross‑functional teams to resolve issues and drive continuous improvement. A degree in a technical field and 4+ years QA experience are required.

Qualifications

• Degree in an Engineering, Science, Quality, or a related Technical field.
• 4+ years of experience in Quality Assurance within FDA/EMEA regulated environments.
• Strong quality auditing experience.
• Strong written and verbal communication skills, capable of clearly articulating complex quality issues.
• Logical thinker with the ability to remain proactive and composed under pressure.
• Proven ability to work effectively both independently and collaboratively within a team.
• Exceptional attention to detail and precision in preparing and reviewing GMP documentation.

Responsibilities

• Completes audits of data, information, procedures, facilities, equipment and systems to ensure compliance with SOPs, GMPs and regulations.
• Review and approve production and analytical documentation for release of drug substance, drug product and finished goods.
• Collaborate with functional areas to resolve audit findings and drive improvements.
• Support product recalls and stock recoveries as appropriate.
• Identify compliance gaps and recommend continuous improvement actions.
• Create and maintain SOPs.
• Perform and review investigations, change controls and CAPAs.

Skills

Quality auditing

Communication

Attention to detail

Independent & team worker

Education

Engineering/Science/Quality or related technical field

Job description

PE Global is seeking a Quality Auditor for a leading pharmaceutical company in Tipperary, Ireland. This 11‑month contract role sits within Global Development Quality (GDQ) and supports GMP QA activities for the GDQ IMP Licence at the site.

The role involves auditing data and systems, reviewing release documentation, and collaborating with cross‑functional teams to resolve issues and drive continuous improvement. A degree in a technical field and 4+ years QA experience are required.