Pharma Quality Auditor — GMP Compliance & QA

Life Science Recruitment; Tipperary; On-site; EUR 55,000 - 75,000; Full time

Job summary

Life Science Recruitment is partnering with a pharmaceutical organisation in Tipperary. The role sits within Global Development Quality (GDQ) and supports GMP Quality Assurance activities for the GDQ IMP Licence at the site.

The candidate will audit data, procedures, facilities and systems, review documentation for release, and participate in CAPA and change control processes to ensure GMP compliance and regulatory adherence.

Qualifications

• Degree in an Engineering or Science discipline.
• Significant industrial experience.
• Experience with GMP quality systems and regulatory requirements.

Responsibilities

• Completes audits of data, information, procedures, facilities, equipment and systems to ensure compliance to SOPs, GMPs and applicable regulations.
• Review and approve production and analytical documentation accompanying the release of drug substances and products to ensure conformance to SOPs, GMP and regulatory requirements.
• Communicate and collaborate with cross-functional areas to resolve comments and issues during audit and review.
• Support product recalls and stock recoveries as appropriate.
• Identify compliance gaps and make recommendations for continuous improvement.
• Create and maintain assigned SOPs.
• Perform and review investigations, change controls and CAPAs.

Skills

Audit experience

GMP knowledge

cGMP compliance

Regulatory understanding

Education

Degree in Engineering/Science

Job description

Life Science Recruitment is partnering with a pharmaceutical organisation in Tipperary. The role sits within Global Development Quality (GDQ) and supports GMP Quality Assurance activities for the GDQ IMP Licence at the site.

The candidate will audit data, procedures, facilities and systems, review documentation for release, and participate in CAPA and change control processes to ensure GMP compliance and regulatory adherence.