QA Specialist

Ipsen; Wrexham; On-site; GBP 60,000 - GBP 80,000; Full time

Job summary

A leading pharmaceutical company in Wrexham is seeking a QA professional to provide oversight in documentation and processes during facility set-up. Key responsibilities include supporting batch record reviews and leading investigations into deviations. The ideal candidate will have experience in the pharma industry, strong knowledge of GMP and regulatory requirements. Join a dynamic team committed to excellence and innovation in pharmaceutical manufacturing.

Qualifications

• Experience in a similar role in pharma or biopharma.
• Strong knowledge of GMP, validation, and regulatory requirements.
• Experience in sterile manufacturing environments and batch release is highly preferred.

Responsibilities

• Provide QA oversight for documentation and processes during facility set-up.
• Support batch record review and ensure timely, compliant batch release.
• Lead investigations into deviations, OOS, CAPAs, and change controls.
• Deliver training and guidance on GMP and quality standards.
• Represent QA in site projects and regulatory inspections.
• Drive continuous improvement and promote a proactive quality culture.

Skills

Experience in a similar role

Knowledge of GMP

Experience in sterile manufacturing

Strong knowledge of regulatory requirements

Job description

Overview

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!

What You’ll Do

• Provide QA oversight for documentation and processes during the NDP facility set-up and beyond
• Support batch record review and ensure timely, compliant batch release.
• Lead investigations into deviations, OOS, CAPAs, and change controls.
• Deliver training and guidance on GMP and quality standards across teams.
• Represent QA in site projects and regulatory inspections.
• Drive continuous improvement and promote a proactive quality culture.

What We’re Looking For

• Experience in a similar role in pharma or biopharma.
• Strong knowledge of GMP, validation, and regulatory requirements.
• Experience in sterile manufacturing environments and batch release is highly preferred.

Apply now and be part of a milestone moment in pharmaceutical manufacturing at our Wrexham site.