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: Permanent position with competitive salary and opportunities for professional growth.
- Other info: Collaborative environment with strong focus on quality and regulatory compliance.
- 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 required.
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
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 in Deeside employer: RRxCo.
Join a leading pharmaceutical manufacturing facility in Deeside, North Wales, where innovation meets excellence in the field of oncology therapeutics. As a Qualified Person, you will thrive in a collaborative work culture that prioritises regulatory compliance and quality oversight, while benefiting from continuous professional development opportunities. With state-of-the-art facilities and a commitment to employee growth, this is an exceptional place to advance your career in a meaningful and impactful way.
StudySmarter Expert Advice🤫
We think this is how you could land Qualified Person in Deeside
✨Network Like a Pro
Get out there and connect with people in the industry! Attend conferences, workshops, or local meetups related to pharmaceuticals and biologics. You never know who might have a lead on your dream QP role!
✨Show Off Your Expertise
When you get the chance to chat with potential employers, don’t hold back! Share your extensive experience in GxP environments and your knowledge of GMP regulations. Let them see why you’re the perfect fit for their team.
✨Ace the Interview
Prepare for those interviews by brushing up on common questions for Qualified Persons. Think about how your past experiences align with the responsibilities listed in the job description. Confidence is key, so practice makes perfect!
✨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 are proactive about their job search!
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 the perfect fit for our team. Mention specific experiences that relate to the responsibilities listed, like your familiarity with GMP regulations or your interactions with regulatory authorities.
Showcase Your Achievements:Don’t just list your duties; showcase your achievements! Use quantifiable results where possible to demonstrate your impact in previous roles. This helps us see the value you can bring to our facility in Deeside.
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 directly and ensures you don’t miss out on any important updates from us!
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 the role but also understand the critical compliance aspects.
✨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 in GxP environments will help demonstrate your expertise and suitability for the position.
✨Communicate Clearly
Strong communication skills are key for a Qualified Person. Practice articulating complex concepts in a straightforward manner. This will not only help during the interview but also reflect your ability to interface effectively with stakeholders and regulatory bodies.
✨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.
