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- Tasks: Ensure compliance and certification of medicinal products in a cutting-edge pharmaceutical facility.
- Company: Specialised pharmaceutical manufacturer focused on advanced 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 leadership and stakeholder engagement.
- Why this job: Join a dynamic team making a real impact in the fast-growing field of biologics.
- Qualifications: Degree in a scientific discipline and 10 years' experience in GxP environments.
The predicted salary is between 48000 - 72000 £ 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 Deeside employer: RRxCo.TM
Contact Detail:
RRxCo.TM Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualified Person in Deeside
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work in GxP environments. A friendly chat can lead to insider info about job openings that might not even be advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP regulations and the latest trends in biologics manufacturing. We recommend practising common interview questions with a friend or using mock interview tools to boost your confidence.
✨Tip Number 3
Showcase your expertise! During interviews, share specific examples of how you've ensured compliance and managed quality systems in previous roles. This will demonstrate your hands-on experience and make you stand out as a candidate.
✨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 with our platform.
We think you need these skills to ace Qualified Person in Deeside
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 align with the job description. We want to see how your background fits perfectly 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 the role and how your skills can contribute to our team. Be sure to mention your experience with regulatory compliance and product release, as these are key aspects of the position.
Showcase Relevant Experience: When detailing your work history, focus on your experience in sterile or biologics manufacturing. We love seeing specific examples of how you've managed quality systems or interacted with regulatory authorities, so don’t hold back!
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 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 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. Highlighting your 10+ years of experience in GxP environments will help demonstrate your expertise and suitability for the role.
✨Understand the Company’s Focus
Research the company’s work in advanced antibody, protein, and peptide drug conjugate technologies. Being able to discuss how your background aligns with their focus on oncology therapeutics will set you apart as a candidate who is genuinely interested in their mission.
✨Prepare Questions
Think of insightful questions to ask during the interview about their quality strategy and how they handle compliance challenges. This shows that you’re proactive and engaged, and it gives you a chance to assess if the company is the right fit for you.