Quality Auditor - GMP Compliance & Audit Specialist

PE Global; Tipperary; On-site; EUR 65,000 - 90,000; Full time

Job summary

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

You will audit data, methods, facilities and systems, review release documentation, and help drive continuous improvement through CAPA, deviations and change controls.

Qualifications

• Degree in 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.
• Logical thinker with the ability to remain proactive under pressure.
• Proven ability to work independently and collaboratively within a team.
• Exceptional attention to detail and precision in GMP documentation.

Responsibilities

• Completes audits of data, information, procedures, facilities, equipment and systems (incl. computer systems) to ensure compliance to SOPs, GMPs and regulations.
• Review and approve production and analytical documentation for release of drug substances, products and packaged finished goods.
• Communicate and collaborate with cross-functional areas to resolve audit comments and issues.
• Support product recalls and stock recoveries as appropriate.
• Identify compliance gaps and recommend continuous improvement.

Skills

Quality auditing

Auditing experience

Communication skills

Attention to detail

Education

Engineering/Science/Quality degree

Job description

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

You will audit data, methods, facilities and systems, review release documentation, and help drive continuous improvement through CAPA, deviations and change controls.