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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: Competitive salary, career development opportunities, and a dynamic work environment.
- Other info: Collaborate with regulatory authorities and lead quality strategies in a state-of-the-art facility.
- Why this job: Join a fast-growing sector and make a real impact on life-saving therapies.
- Qualifications: Degree in a scientific discipline and 10 years' experience in GxP environments.
The predicted salary is between 60000 - 80000 £ 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 in London employer: RRxCo.
Contact Detail:
RRxCo. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualified Person in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical and biologics sectors. Attend industry events or webinars to meet potential employers and get your name out there.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP regulations and quality systems. Be ready to discuss your experience with regulatory authorities and how you've ensured compliance in past roles.
✨Tip Number 3
Showcase your leadership skills! Think of examples where you've led teams or projects, especially in GxP environments. Employers love to see candidates who can take charge and drive quality initiatives.
✨Tip Number 4
Don't forget to apply through our website! We have loads of opportunities that might be perfect for you. Plus, it’s a great way to ensure your application gets seen by the right people.
We think you need these skills to ace Qualified Person in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in GxP environments and any relevant qualifications. We want to see how your background aligns with the role of a Qualified Person, so don’t hold back on showcasing your skills!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this role. Mention your experience with regulatory compliance and product release, and let us know what excites you about working in the pharmaceutical sector.
Showcase Your Regulatory Knowledge: Since this role involves interfacing with regulatory authorities, make sure to highlight your knowledge of GMP regulations and any direct experience you have. We love seeing candidates who are well-versed in the legal frameworks that govern our industry!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates. Plus, we love seeing applications come in through our own platform!
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 and EU Directive 2001/83. Being able to discuss these regulations confidently will show that you're not just familiar with the role but also understand the critical compliance aspects.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've successfully managed GxP environments or interacted with regulatory authorities. Highlighting your extensive experience in quality systems and product release will demonstrate your capability as a Qualified Person.
✨Communicate Clearly
Strong communication skills are key for this role. Practice articulating complex concepts simply and clearly, especially when discussing batch manufacturing and testing documentation. This will help you connect with the interviewers and showcase your stakeholder management skills.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's quality strategy and how they handle compliance challenges. This shows your genuine interest in the role and helps you assess if the company aligns with your career goals.