QA Specialist — GMP, CAPA & Compliance

Morgan McKinley; Limerick; On-site; EUR 45,000 - 65,000; Full time

Job summary

Morgan McKinley is seeking a QA Specialist to maintain site compliance across manufacturing and quality systems in a regulated environment. The role focuses on QA activities, document control, and continuous improvement within Raheen operations.

The position requires experience in pharmaceutical quality, CAPA, and regulatory adherence, with responsibilities spanning investigations, audits, and training of personnel.

Qualifications

• BS/BA in scientific discipline required.
• 2+ years of relevant pharmaceutical or related industry experience.
• 5+ years or MS 4+ years of relevant work experience.

Responsibilities

• Ensure compliance with quality across manufacturing, QA, facilities and materials handling.
• Maintain regulatory compliance per cGMP requirements.
• Collaborate with cross-functional teams to resolve issues and investigations.
• Review and approve CAPA, SOPs, and GxP documents.
• Lead root cause analysis and ensure CAPA is implemented.
• Monitor quality system metrics and participate in audits.
• Train personnel on quality system processes.
• Participate in continuous improvement initiatives.
• Perform additional duties as requested.

Education

BS/BA in scientific discipline

BS/BA with 2+ years experience

BS/BA with 5+ years or MS with 4+ years

Job description

Morgan McKinley is seeking a QA Specialist to maintain site compliance across manufacturing and quality systems in a regulated environment. The role focuses on QA activities, document control, and continuous improvement within Raheen operations.

The position requires experience in pharmaceutical quality, CAPA, and regulatory adherence, with responsibilities spanning investigations, audits, and training of personnel.