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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 growth, and the chance to work with advanced technologies.
- Other info: Join a dynamic team dedicated to quality and regulatory excellence.
- Why this job: Make a real impact in the fast-growing field of biologics and oncology.
- Qualifications: Degree in a scientific discipline and 10+ years 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.TM
Contact Detail:
RRxCo.TM 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. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP regulations and the specific requirements for a Qualified Person. We recommend practising common interview questions and scenarios related to regulatory compliance and product release. Confidence is key!
✨Tip Number 3
Showcase your experience! When you get the chance to chat with hiring managers, highlight your extensive background in GxP environments and your interactions with regulatory authorities. We want to see how your skills align with their needs.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for passionate individuals who are ready to make an impact in the pharmaceutical industry.
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 expertise!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for our team. Mention specific experiences that relate to the responsibilities listed in the job description, especially around regulatory compliance and product release.
Showcase Your Regulatory Knowledge: Since this role involves interfacing with regulatory authorities, make sure to highlight your knowledge of GMP regulations and any direct experiences you’ve had. We love candidates who can demonstrate their understanding of the regulatory landscape!
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’re considered for the role. Plus, it shows you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at RRxCo.TM
✨Know Your Regulations
Make sure you brush up on 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 legal framework that governs it.
✨Showcase Your Experience
Prepare specific examples from your past roles where you’ve successfully managed GxP compliance or interacted with regulatory authorities. This will help demonstrate your extensive experience and how it aligns with the responsibilities of a Qualified Person.
✨Communicate Clearly
Strong communication skills are key in this role. Practice articulating complex concepts in a straightforward manner, especially when discussing quality systems or batch release processes. This will help you connect with the interviewers and showcase your stakeholder management abilities.
✨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 is the right fit for you.