QA Technologist - cGMP, Audits & Compliance (1-Year FTC)

Ipsen Biopharmaceuticals Inc.; Dublin; On-site; EUR 45,000 - 60,000; 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. You will help ensure cGMP compliance, support quality processes and contribute to operational excellence in a state-of-the-art API facility.

The ideal candidate has a BSc in Science with at least 1 year of QA experience, strong knowledge of cGMP (EMEA, FDA, ICH), solid quality systems, and excellent teamwork and communication skills.

Qualifications

• BSc in Science or related field.
• Minimum 1 year of QA experience.
• Knowledge of cGMP (EMEA, FDA, ICH) and quality systems.
• Strong teamwork and communication skills.

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

Teamwork

Communication

Education

BSc in Science

Tools

SAP PM

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. You will help ensure cGMP compliance, support quality processes and contribute to operational excellence in a state-of-the-art API facility.

The ideal candidate has a BSc in Science with at least 1 year of QA experience, strong knowledge of cGMP (EMEA, FDA, ICH), solid quality systems, and excellent teamwork and communication skills.