QA Specialist NDP

Title

QA Specialist – NDP

Ipsen Biopharm Ltd

Wrexham, UK

As a QA Specialist – NDP, you will support 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.

• Provide QA oversight for the development and implementation of processes and procedures for Building7, 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 inspection 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.

• 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.

• Extensive QA experience, particularly within sterile or aseptic manufacturing environments.
• Knowledge of EU GMP Annex1 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 ICHQ9 Quality Risk Management principles.

We are committed to creating a workplace where everyone feels heard, valued, and supported, and we embrace inclusion and equal opportunities.