At a Glance
- Tasks: Ensure quality oversight in a new pharmaceutical facility and support compliance with GMP standards.
- Company: Ipsen Biopharm Ltd, a leader in the pharmaceutical industry.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Fast-paced environment with excellent career advancement opportunities.
- Why this job: Join a dynamic team and make a real impact on healthcare through quality assurance.
- Qualifications: Experience in QA within pharmaceuticals and strong knowledge of GMP.
The predicted salary is between 40000 - 50000 £ per year.
As a QA Specialist – NDP, you will support 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.
Responsibilities
- Provide QA oversight for the development and implementation of processes and procedures for Building7, 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 inspection 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 Experience
- Extensive QA experience, particularly within sterile or aseptic manufacturing environments.
- Knowledge of EU GMP Annex1 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 ICHQ9 Quality Risk Management principles.
We are committed to creating a workplace where everyone feels heard, valued, and supported, and we embrace inclusion and equal opportunities.
QA Specialist NDP in Wrexham employer: Ipsen Biopharm Ltd
Ipsen Biopharm Ltd is an exceptional employer, offering a dynamic work environment in Wrexham, UK, where you can play a pivotal role in the launch of a state-of-the-art pharmaceutical manufacturing facility. With a strong commitment to employee growth, continuous improvement, and a culture that values collaboration and innovation, Ipsen provides comprehensive training and development opportunities, ensuring that every team member can thrive while contributing to meaningful advancements in healthcare.
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 people in the industry, especially those at Ipsen Biopharm. A friendly chat can open doors and give you insights that might just land you an interview.
✨Tip Number 2
Prepare for the interview by brushing up on your GMP knowledge and QA processes. We want you to showcase your expertise, so think of examples from your past experience that highlight your problem-solving skills.
✨Tip Number 3
Don’t forget to follow up after your interview! A quick thank-you email can keep you fresh in their minds and show your enthusiasm for the role. Plus, it’s a great chance to reiterate why you’re the perfect fit.
✨Tip Number 4
Check out our website for more opportunities! We regularly update our listings, and applying directly through us can sometimes give you an edge. Let’s get you that QA Specialist role!
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 the pharmaceutical industry, especially any work with GMP and batch record reviews. We want to see how your skills align with what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance and how you can contribute to our new facility. Be sure to mention any specific experiences that relate to the responsibilities listed in the job description.
Showcase Your Problem-Solving Skills:In your application, don’t forget to highlight your problem-solving abilities. Share examples of how you've tackled complex issues in the past, especially in a QA context. We love seeing candidates who can think on their feet and drive continuous improvement!
Apply Through Our Website:We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to upload all your documents in one go. Plus, it shows us you’re serious about joining our team at Ipsen Biopharm!
How to prepare for a job interview at Ipsen Biopharm Ltd
✨Know Your GMP Inside Out
Make sure you brush up on your Good Manufacturing Practice (GMP) knowledge. Since the role involves ensuring compliance with GMP requirements, being able to discuss specific examples of how you've applied these principles in past roles will really impress the interviewers.
✨Showcase Your Problem-Solving Skills
Prepare to share examples of complex issues you've resolved in a QA context. Think about times when you had to troubleshoot during manufacturing activities or handle deviations. This will demonstrate your ability to think on your feet and contribute effectively to the team.
✨Familiarise Yourself with the Facility's Needs
Research Ipsen Biopharm Ltd and their new facility in Wrexham. Understanding their operational goals and challenges will help you tailor your responses and show that you're genuinely interested in contributing to their success.
✨Practice Your Communication Skills
Since the role requires delivering training and guidance, practice explaining complex QA concepts in simple terms. This will not only help you in the interview but also show that you can effectively communicate with cross-functional teams.
