QA Specialist NDP

Join Our Award-Winning Team at Ipsen Wrexham

At Ipsen, we are committed to improving the lives of patients, with a special focus on advancing neuroscience therapies. Our Wrexham site is a vital part of this mission, delivering cutting-edge solutions in a dynamic and collaborative environment. We are proud to be Great Place to Work certified and a Shingo Bronze Medallion holder, reflecting our commitment to excellence, innovation, and continuous improvement.

With a recent £24 million investment in the site and a further £86.4 million expansion underway, there has never been a more exciting time to join us. If you are passionate about making an impact and want to be part of a team that values growth, innovation, and excellence, then Ipsen could be where you thrive!

Role summary

As a QA Specialist – NDP, you will play a key role in supporting a brand-new pharmaceutical manufacturing facility, ensuring robust quality oversight, operational readiness, and compliance with GMP requirements. You will partner closely with cross-functional teams to enable successful facility qualification, commercialisation, and ongoing manufacturing excellence.

In this role you will:

• Provide Quality Assurance oversight for the development and implementation of processes and procedures for the new Building 7 facility, ensuring alignment with GMP and Ipsen standards.
• Review and maintain key operational documentation (SOPs, batch records, logbooks) and support deviation investigations, CAPAs, change controls, and OOS events.
• Perform batch record review and provide real-time QA oversight during manufacturing activities to ensure compliant and timely batch release.
• Act as a technical QA expert, supporting troubleshooting, resolving complex issues, and contributing to site projects and regulatory inspections readiness.
• Deliver training and guidance on quality standards, procedures, and documentation to site teams, enabling a smooth transition to routine operations.
• Drive continuous improvement by analysing quality metrics, identifying opportunities, and promoting a proactive quality culture across the site.

Requirements:

• Significant QA experience within the pharmaceutical or biopharmaceutical industry
• Strong knowledge of GMP, validation principles, and regulatory expectations
• Experience in batch record review and supporting batch release activities
• Excellent communication, problem-solving, and organisational skills
• Ability to work both independently and collaboratively in a fast-paced, evolving environment
• Degree, diploma or equivalent in a scientific discipline

Preferred:

• Extensive QA experience, particularly within sterile or aseptic manufacturing environments
• Knowledge of EU GMP Annex 1 and contamination control strategies
• Experience supporting new facility start-up, expansion, or technology transfer projects
• Familiarity with cleanroom environments (Grade A/B), aseptic techniques, and gowning practices
• Experience with quality systems such as SAP, Blue Mountain, or electronic QMS platforms
• Understanding and application of ICH Q9 Quality Risk Management principles

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