Title: QA Officer 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 https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram. 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! We are excited to announce an opportunity for a Quality Assurance (QA) Officer to join our dynamic QA Operations team, reporting into the QA Process Leader. As QA Officer, you will have the opportunity to spend time with the Production teams performing oversight and providing coaching and mentoring when required. As a result, we are looking for someone who can accommodate a 4 on/4 off shift pattern consisting of two days and two nights 12 hour shifts (days: 6am-6:15pm. Nights: 6pm-6:15am). Key responsibilities: Review and approve batch documentation to support QPs in certification and release of site-manufactured batches per EU regulations. Provide Quality Oversight across manufacturing streams using cGMP guidelines and industry standards. Support routine operational activities and continuous improvements in site manufacturing. Participate in Quality Management Processes (Unplanned Events, Complaints, CAPA, Change Control, Product Recall, Blue Mountain, SAP). Skills, knowledge and experience: Experience reviewing batch documentation Knowledge of aseptic manufacturing processes is desirable Experience with clean rooms is highly preferred Experience working in QA environment with a sound knowledge of cGMP and QRM Experience with QEVs (Quality Events) or similar Methodical, proactive and attentive to detail If you’re passionate about ensuring quality for patients, and meet the requirements then please go ahead and apply! LI-Onsite IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.