GMP QA Technologist – Biopharma API (1-Year Contract)

Ipsen; Dublin; On-site; EUR 42,000 - 54,000; Full time

Job summary

Ipsen Manufacturing Ireland Ltd in Dublin is seeking a QA Technologist to join the Quality team on a 1-year fixed-term contract. Reporting to the QA Manager, the role ensures compliance with cGMP regulations and supports quality processes across manufacturing activities.

The successful candidate will review batch records, participate in internal audits, support investigations and training, and collaborate with cross-functional teams to maintain product quality and regulatory readiness.

Qualifications

• Knowledge of current Good Manufacturing Practise (cGMP) across EMEA/FDA/ICH
• Experience with quality systems and documentation
• Strong teamwork and clear 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 EHS systems, risk assessments and safety procedures.

Skills

cGMP knowledge

Quality systems

Team working

Communication skills

Education

BSc in Science

Job description

Ipsen Manufacturing Ireland Ltd in Dublin is seeking a QA Technologist to join the Quality team on a 1-year fixed-term contract. Reporting to the QA Manager, the role ensures compliance with cGMP regulations and supports quality processes across manufacturing activities.

The successful candidate will review batch records, participate in internal audits, support investigations and training, and collaborate with cross-functional teams to maintain product quality and regulatory readiness.