QA Technologist

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

Title:

QA Technologist

Company:

Ipsen Manufacturing Ireland Ltd

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company's success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram .

Job Description:

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.

We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace "The Real Us". The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.