Quality Assurance Technologist – Drive GMP Excellence

Ipsen Manufacturing Ireland Ltd; Dublin; On-site; EUR 45,000 - 65,000; Full time

Job summary

Ipsen in Ireland operates a state-of-the-art manufacturing facility dedicated to producing Active Pharmaceutical Ingredients (API) for our core product portfolio. We are seeking a QA Technologist to join our Quality team in Dublin.

Reporting to the QA Manager, the role involves ensuring compliance with current Good Manufacturing Practice (cGMP) regulations and guidelines, supporting quality processes, and contributing to operational excellence.

Qualifications

• Knowledge of cGMP (EMEA, FDA, ICH).
• Experience with quality systems and inspections.
• Strong teamwork and communication abilities.

Responsibilities

• Review and approve Batch Record Documentation and cGMP documentation.
• Conduct QA inspections of production equipment and facilities.
• Oversee investigations, root cause analysis, and quality event workflows.
• Perform internal audits and support external regulatory inspections.
• Generate Annual Product Quality Reviews and conduct cGMP training.
• Collaborate with manufacturing teams to support production plans and batch record reviews.
• Assist in validation, change control activities, and SAP PM tasks.
• Ensure compliance with Environmental, Health & Safety (EHS) systems, risk assessments, and safety procedures.

Skills

cGMP knowledge

Quality systems

Team-working

Communication skills

Education

BSc in Science

Job description

Ipsen in Ireland operates a state-of-the-art manufacturing facility dedicated to producing Active Pharmaceutical Ingredients (API) for our core product portfolio. We are seeking a QA Technologist to join our Quality team in Dublin.

Reporting to the QA Manager, the role involves ensuring compliance with current Good Manufacturing Practice (cGMP) regulations and guidelines, supporting quality processes, and contributing to operational excellence.