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- Tasks: Certify and release batches, ensuring compliance with UK and EU regulations.
- Company: Leading pharmaceutical company in Cheshire focused on quality and innovation.
- Benefits: Competitive salary, career development opportunities, and a commitment to quality.
- Why this job: Join a dynamic team and make a real impact in the pharmaceutical industry.
- Qualifications: Must be an eligible Qualified Person with experience in sterile manufacturing.
- Other info: Great opportunity for growth in a supportive and quality-driven environment.
The predicted salary is between 48000 - 72000 £ per year.
Blackfield Associates is partnered with a leading pharmaceutical company based in Cheshire in the search for a Qualified Person. As a Qualified Person, you will be responsible for batch certification and release (commercial & clinical) under UK and EU GMP and Annex 16, ensuring compliance with regulatory requirements and Quality Technical Agreements. You will provide QA leadership across sterile manufacturing, oversee GMP elements of product development, including clinical material, and support a strong commitment to quality across site operations.
Responsibilities
- Acting as a named Qualified Person on MIA and IMP licences, certifying and releasing commercial and clinical batches in line with UK/EU GMP and Annex 16.
- Providing QA leadership and oversight across sterile manufacturing operations to ensure ongoing regulatory compliance.
- Performing quality review and approval of manufacturing data, APQRs, deviations, CAPA, change control, and regulatory submissions.
- Supporting internal audits, regulatory inspections, and providing GMP oversight for CMOs and external partners.
Qualifications
The correct candidate for this opportunity will be an eligible Qualified Person with extensive experience in sterile manufacturing and Quality Assurance. They will have demonstrable experience acting as a named QP on MIA and IMP licences, leading batch certification and release activities, and providing quality oversight across technical operations. A degree in a relevant scientific discipline is essential, and experience with Lean/Six Sigma or Lead Auditor certification is desirable.
Qualified Person in London employer: Blackfield Associates
Contact Detail:
Blackfield Associates 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 professionals in the pharmaceutical industry, especially those who work in QA and sterile manufacturing. Use platforms like LinkedIn to connect and engage with them; you never know who might have the inside scoop on job openings.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of UK and EU GMP regulations. Be ready to discuss how your experience aligns with the responsibilities of a Qualified Person. We recommend practising common interview questions related to batch certification and quality oversight.
✨Tip Number 3
Showcase your expertise! Create a portfolio that highlights your achievements in quality assurance and sterile manufacturing. Include examples of successful projects, audits, or certifications you've led. This will help you stand out when applying through our website.
✨Tip Number 4
Stay updated on industry trends and regulatory changes. Follow relevant blogs, attend webinars, and join professional groups. This not only enhances your knowledge but also gives you great talking points during interviews, showing your commitment to quality in the field.
We think you need these skills to ace Qualified Person in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Qualified Person role. Highlight your experience in sterile manufacturing and Quality Assurance, especially any relevant certifications or licences you've held. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for the role. Mention specific experiences that demonstrate your QA leadership and compliance knowledge. Let us know what excites you about working with us!
Showcase Your Technical Skills: In your application, don't forget to showcase your technical skills related to batch certification and regulatory compliance. We’re looking for someone who can hit the ground running, so make sure we see your expertise in action!
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of applications and ensures you get all the updates directly from us. Plus, it shows you're keen on joining our team!
How to prepare for a job interview at Blackfield Associates
✨Know Your GMP Inside Out
Make sure you brush up on your knowledge of UK and EU GMP regulations, especially Annex 16. Being able to discuss specific compliance scenarios and how you've handled them in the past will show that you're not just familiar with the rules, but that you can apply them effectively.
✨Showcase Your QA Leadership Skills
Prepare examples of how you've provided QA leadership in sterile manufacturing environments. Think about times when you led a team through audits or inspections, and be ready to discuss the outcomes. This will demonstrate your capability to oversee operations and ensure compliance.
✨Be Ready for Technical Questions
Expect technical questions related to batch certification and release processes. Brush up on your experience with MIA and IMP licences, and be prepared to explain your role in quality reviews, deviations, and CAPA. The more specific you can be, the better!
✨Highlight Continuous Improvement Experience
If you have experience with Lean/Six Sigma methodologies, make sure to highlight it. Discuss how you've implemented these practices in previous roles to improve quality and efficiency. This shows that you're committed to ongoing improvement, which is crucial in the pharmaceutical industry.
