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- Tasks: Certify and release batches, ensuring compliance with UK and EU GMP regulations.
- Company: Leading pharmaceutical company in Cheshire with a commitment to quality.
- Benefits: Competitive salary, career development opportunities, and a supportive work environment.
- 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 fast-paced, quality-focused 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 employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualified Person
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work in QA or sterile manufacturing. 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 UK and EU GMP regulations. We all know that confidence is key, so being well-versed in these areas will help you shine when discussing your experience as a Qualified Person.
✨Tip Number 3
Don’t forget to showcase your leadership skills! When you get the chance to talk about your past experiences, highlight how you've provided QA oversight and led teams in sterile manufacturing. This will show potential employers that you’re ready to take charge.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and eager to join our team. So, don’t hesitate – hit that apply button!
We think you need these skills to ace Qualified Person
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, and don’t forget to mention any relevant qualifications like your degree or certifications.
Showcase Your Experience: In your cover letter, showcase your experience with batch certification and release under UK/EU GMP. Use specific examples to demonstrate how you've provided QA leadership and ensured compliance in previous roles.
Be Clear and Concise: Keep your application clear and concise. Avoid jargon and make sure your points are easy to understand. We want to see your qualifications and experience without having to sift through unnecessary fluff!
Apply Through Our Website: Don’t forget to apply 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!
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. Be prepared to discuss how you've applied these standards in your previous roles, as this will show your expertise and commitment to quality.
✨Showcase Your QA Leadership Skills
Think of specific examples where you've provided QA leadership in sterile manufacturing. Highlight your experience with batch certification and release, and be ready to explain how you ensured compliance during those processes.
✨Prepare for Technical Questions
Expect technical questions related to quality review, APQRs, and CAPA. Brush up on your knowledge of these areas and prepare to discuss any challenges you've faced and how you overcame them.
✨Demonstrate Your Continuous Improvement Mindset
If you have experience with Lean/Six Sigma, be sure to mention it! Discuss how you've implemented improvements in past roles and how that aligns with the company's commitment to quality across site operations.
