GMP Quality Assurance Specialist – Pharma/Biotech Audits

PSC Biotech Corporation; Munster; On-site; EUR 60,000 - 80,000; Full time

Job summary

PSC Biotech Corporation in Ireland seeks a contractor to support GMP Quality Assurance activities for the GDQ IMP Licence. You will perform data and document audits, ensure release conformance, and collaborate with cross-functional teams to maintain quality standards.

The role requires an Engineering or Science degree with substantial industrial GMP experience and a focus on quality processes across client sites in a global biotech environment.

Qualifications

• Degree in Engineering or Science discipline.
• 4–5 years industrial experience.
• GMP quality assurance exposure.

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 substance, drug product and packaged finished goods to ensure conformance to SOPs, GMP and regulatory requirements.
• Collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities; resolve comments 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.

Skills

Audit experience

GMP knowledge

Quality Assurance

Regulatory understanding

Education

Engineering or Science degree

Job description

PSC Biotech Corporation in Ireland seeks a contractor to support GMP Quality Assurance activities for the GDQ IMP Licence. You will perform data and document audits, ensure release conformance, and collaborate with cross-functional teams to maintain quality standards.

The role requires an Engineering or Science degree with substantial industrial GMP experience and a focus on quality processes across client sites in a global biotech environment.