At a Glance
- Tasks: Ensure compliance and certification of medicinal products in a cutting-edge pharmaceutical facility.
- Company: Specialised pharmaceutical manufacturer focused on advanced oncology therapeutics.
- Benefits: Competitive salary, career development, and the chance to work with innovative technologies.
- Other info: Opportunity to interface with regulatory authorities and shape quality strategy.
- Why this job: Join a dynamic team making a real impact in the fast-growing field of bioconjugation.
- Qualifications: Degree in a scientific discipline and 10 years' experience in GxP environments required.
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
Candidate Profile
- 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 - Pharmaceuticals in Deeside employer: RRxCo.
Join a leading pharmaceutical manufacturing facility in Deeside, North Wales, where innovation meets excellence in the rapidly evolving field of oncology therapeutics. As a Qualified Person, you will thrive in a collaborative work culture that prioritises compliance and quality, while benefiting from extensive employee growth opportunities and a commitment to professional development. With state-of-the-art facilities and a focus on advanced bioconjugation processes, this is an exceptional opportunity for those seeking meaningful and rewarding employment in a dynamic environment.
StudySmarter Expert Advice🤫
We think this is how you could land Qualified Person - Pharmaceuticals in Deeside
✨Network Like a Pro
Get out there and connect with people in the industry! Attend conferences, workshops, or even local meet-ups. We all know that sometimes it’s not just what you know, but who you know that can help you land that Qualified Person role.
✨Show Off Your Expertise
When you get the chance to chat with potential employers, don’t hold back on showcasing your knowledge of GMP regulations and quality systems. We want to see your passion for pharmaceuticals shine through, so be ready to discuss your experience in sterile and biologics manufacturing!
✨Prepare for the Interview
Do your homework before the interview! Research the company and its products, especially in oncology therapeutics. We recommend preparing some questions about their quality strategy and how you can contribute as a QP. It shows you’re genuinely interested and ready to jump in.
✨Apply Through Our Website
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 take the initiative to engage directly with us. Let’s get you that Qualified Person position!
We think you need these skills to ace Qualified Person - Pharmaceuticals in Deeside
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to highlight your experience as a Qualified Person. Focus on your GxP experience and any relevant certifications that align with the job description.
Craft a Compelling Cover Letter:Your cover letter should tell us why you're the perfect fit for this role. Mention specific experiences that demonstrate your knowledge of GMP regulations and your ability to manage quality systems.
Showcase Your Regulatory Experience:Since this role involves interfacing with regulatory authorities, be sure to emphasise your experience in this area. Share examples of how you've successfully navigated compliance challenges in the past.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates!
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.
✨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 the oncology therapeutics field will impress your interviewers and show your genuine interest in the position.
✨Prepare Questions
Think of insightful questions to ask during the interview. Inquire about their quality strategy or how they handle compliance challenges. This not only shows your engagement but also helps you assess if the company is the right fit for you.
