Title:
QA Officer
Company:
Ipsen Biopharm Ltd
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 24/7 shift pattern.
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!
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.