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- Tasks: Ensure compliance and certification of medicinal products in a cutting-edge pharmaceutical facility.
- Company: Specialised pharmaceutical manufacturer focused on oncology therapeutics.
- Benefits: Permanent position with competitive salary and opportunities for professional growth.
- Other info: Work in a state-of-the-art facility with strong regulatory oversight.
- Why this job: Join a dynamic team making a real impact in advanced drug development.
- Qualifications: Degree in a scientific discipline and 10 years' experience in GxP environments.
The predicted salary is between 36000 - 60000 £ per year.
We are supporting the appointment of an experienced Qualified Person (QP) at a highly specialised pharmaceutical manufacturing facility based in Deeside, North Wales. The site focuses on advanced antibody, protein and peptide drug conjugate technologies, operating within one of the fastest-growing areas of oncology therapeutics. The facility supports development activities from discovery through to clinical development within a state-of-the-art environment designed for highly potent bioconjugation processes.
The Qualified Person will be responsible for performing the full duties of a QP in line with EU and UK regulatory frameworks, ensuring compliant certification and release of medicinal products and investigational medicinal products (IMPs). This role sits within the Quality function and will play a key role in maintaining regulatory compliance, supporting product release and providing strategic quality oversight across the site.
Key Responsibilities- Act as a Qualified Person in accordance with Eudralex Volume 4 Annex 16 and EU Directive 2001/83 as incorporated into UK law
- Review and certify batch manufacturing and testing documentation for product release
- Support the release of Investigational Medicinal Product (IMP) batches
- Ensure compliance with GMP requirements and relevant regulatory expectations
- Manage and review quality system elements including deviations, CAPAs and change controls
- Provide GxP guidance and support across site functions
- Interface with regulatory authorities and customers as required
- Ensure correct documentation and regulatory frameworks are in place for product certification
- Contribute to the development of site and group quality strategy
- Eligible to act as a Qualified Person under UK legislation
- Degree in Chemistry, Pharmacy, Biology or a related scientific discipline
- Minimum 10 years’ experience working in GxP environments within the pharmaceutical or biologics sector
- Extensive experience interacting with regulatory authorities
- Strong knowledge of GMP regulations and pharmaceutical quality systems
- Experience within sterile, biologics, or complex manufacturing environments preferred
- Strong leadership, communication and stakeholder management skills
Qualified Person employer: RRxCo.
Contact Detail:
RRxCo. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualified Person
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical and biologics sectors. Attend industry events or webinars, and don’t be shy about introducing yourself. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP regulations and the specific technologies used in the role. We recommend practising common interview questions related to quality oversight and regulatory compliance to show you’re the perfect fit.
✨Tip Number 3
Showcase your experience! When you get the chance to chat with potential employers, highlight your past roles in GxP environments and any interactions with regulatory authorities. This will demonstrate your expertise and make you stand out.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and engaged in their job search.
We think you need these skills to ace Qualified Person
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Qualified Person role. Highlight your experience in GxP environments and any relevant qualifications that match the job description. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for the role and how your skills can contribute to our team. Keep it concise but impactful – we love a good story!
Showcase Relevant Experience: When detailing your experience, focus on your work with regulatory authorities and your knowledge of GMP regulations. We’re looking for someone who can hit the ground running, so make sure we see that expertise front and centre.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from our team!
How to prepare for a job interview at RRxCo.
✨Know Your Regulations
Make sure you brush up on the EU and UK regulatory frameworks, especially Eudralex Volume 4 Annex 16. Being able to discuss these regulations confidently will show that you're not just familiar with them but can apply them in practice.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've successfully managed quality systems or interacted with regulatory authorities. This will help demonstrate your extensive experience in GxP environments and how it aligns with the role of a Qualified Person.
✨Understand the Company’s Focus
Research the company’s work in advanced antibody, protein, and peptide drug conjugate technologies. Being knowledgeable about their products and processes will allow you to tailor your answers and show genuine interest in their mission.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills in real-world scenarios, such as handling deviations or CAPAs. Think through potential situations you might face in the role and how you would address them effectively.