Ipsen in Ireland is represented by a dynamic state-of-the-art manufacturing facility dedicated to producing Active Pharmaceutical Ingredients (API) for our core product portfolio.
We are seeking a
Quality Assurance (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. This opening is available on a 1-year fixed term contract.
Key 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.
Requirements
- Education: BSc in Science.
- Experience: Minimum 1 year of relevant QA experience.
- Skills: Knowledge of cGMP (EMEA, FDA, ICH), quality systems, team-working, and communication skills.
If you are passionate about Quality Assurance and meet the requirements outlined above, we look forward to considering your application. This position offers the opportunity to contribute to essential quality processes, collaborate with cross-functional teams, and support ongoing compliance with industry standards. We look forward to considering your application. Apply today to take the next step in your career!