QA Specialist

Ipsen Group; United Kingdom; On-site; GBP 35,000 - GBP 55,000; Full time

Job summary

A leading biopharmaceutical company in Wrexham is looking for a QA Specialist to oversee documentation and processes for a new drug product facility. This role involves ensuring compliance with GMP standards, leading investigations, and delivering training. The ideal candidate has experience in pharma or biopharma, with strong knowledge of validation and regulatory requirements. Join a committed team focused on innovation and excellence.

Qualifications

• Experience in a similar role in pharma or biopharma.
• Strong knowledge of GMP, validation, and regulatory requirements.
• Experience in sterile manufacturing environments 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.
• Drive continuous improvement and promote a proactive quality culture.

Skills

Experience in a similar role in pharma or biopharma

Strong knowledge of GMP, validation, and regulatory requirements

Experience in sterile manufacturing environments

Job description

Cookie NoticeQA Specialist - New Facility page is loaded## QA Specialist - New Facilitylocations: Wrexhamtime type: Full timeposted on: Posted Todayjob requisition id: R-19935**Title:**QA Specialist - New Facility**Company:**Ipsen Biopharm 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 and follow our latest news on and .**Job Description:**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!**QA Specialist** to support the launch of a brand-new drug product facility on our Wrexham manufacturing site. This facility is a major step forward in our pharmaceutical capabilities, and you’ll play a key role in bringing it online from a quality perspective. Your mission: ensure all documentation, processes, and systems meet GMP standards and are ready for operational excellence.**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.**#LI-Onsite**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.### Get In TouchIntroduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match.