At a Glance
- Tasks: Ensure quality oversight and compliance in a new pharmaceutical manufacturing facility.
- Company: Ipsen Biopharm Ltd, a global biopharmaceutical leader focused on transformative medicines.
- Benefits: Join a Great Place to Work with opportunities for growth and innovation.
- Other info: Exciting expansion underway with a commitment to inclusion and diverse perspectives.
- Why this job: Make a real impact on patients while working in a dynamic, collaborative environment.
- Qualifications: Experience in QA within pharmaceuticals and strong knowledge of GMP standards.
The predicted salary is between 40000 - 50000 £ per year.
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 endeavour 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 Our Award-Winning Team at Ipsen Wrexham. 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!
Role summary: As a QA Specialist – NDP, you will play a key role in supporting 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.
In this role you will:
- Provide Quality Assurance oversight for the development and implementation of processes and procedures for the new Building 7 facility, 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 inspections 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.
Requirements:
- 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.
Preferred:
- Extensive QA experience, particularly within sterile or aseptic manufacturing environments.
- Knowledge of EU GMP Annex 1 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 ICH Q9 Quality Risk Management principles.
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.
QA Specialist NDP in Wrexham employer: Ipsen
Ipsen Biopharm Ltd is an exceptional employer, particularly for those seeking a meaningful role in the biopharmaceutical industry. With a strong commitment to employee growth and a collaborative work culture, our Wrexham site offers exciting opportunities for innovation and excellence, supported by significant investments and a focus on quality assurance. Join us to be part of a passionate team dedicated to making a real impact on patients' lives while thriving in a Great Place to Work certified environment.
StudySmarter Expert Advice🤫
We think this is how you could land QA Specialist NDP in Wrexham
✨Tip Number 1
Network like a pro! Reach out to current or former Ipsen employees on LinkedIn. A friendly chat can give you insider info about the company culture and maybe even a referral!
✨Tip Number 2
Prepare for the interview by diving deep into Ipsen's mission and values. Show us how your passion for quality assurance aligns with our commitment to improving patient lives.
✨Tip Number 3
Practice common QA interview questions, but also be ready for situational ones. We want to see how you handle real-life challenges in a fast-paced environment.
✨Tip Number 4
Don’t forget to follow up after your interview! A quick thank-you email can keep you fresh in our minds and show us you're genuinely interested in joining the Ipsen team.
We think you need these skills to ace QA Specialist NDP in Wrexham
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the QA Specialist role. Highlight your relevant experience in quality assurance, especially within the pharmaceutical industry, and showcase any specific knowledge of GMP and regulatory expectations.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about joining Ipsen and how your skills align with our mission. Don’t forget to mention any experience you have with new facility start-ups or continuous improvement initiatives.
Showcase Your Problem-Solving Skills:In your application, be sure to highlight examples where you've successfully resolved complex issues or contributed to quality improvements. We love candidates who can demonstrate their analytical thinking and proactive approach!
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of success. It’s the easiest way for us to keep track of your application and ensure it gets the attention it deserves!
How to prepare for a job interview at Ipsen
✨Know Your GMP Inside Out
Make sure you brush up on Good Manufacturing Practices (GMP) and any relevant regulations. Ipsen is looking for someone who can demonstrate a strong understanding of these principles, so be prepared to discuss how you've applied them in your previous roles.
✨Showcase Your Problem-Solving Skills
As a QA Specialist, you'll need to tackle complex issues. Think of specific examples from your past experience where you've successfully resolved problems or improved processes. This will show that you can think critically and act decisively in a fast-paced environment.
✨Familiarise Yourself with the Facility
Research Ipsen's new Building 7 facility and its role in the pharmaceutical manufacturing process. Understanding the specifics of the site and its operations will help you tailor your answers and demonstrate your genuine interest in the position.
✨Emphasise Team Collaboration
Ipsen values collaboration, so be ready to discuss how you've worked effectively within cross-functional teams. Share examples of how you've communicated quality standards and trained others, as this will highlight your ability to foster a proactive quality culture.
