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- Tasks: Certify and release batches, ensuring compliance with UK and EU GMP 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: Eligible Qualified Person with experience in sterile manufacturing and Quality Assurance.
- Other info: Ideal for those passionate about quality and regulatory compliance.
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.
Key technical responsibilities include:
- 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.
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 Warrington employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualified Person in Warrington
✨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 aren't even 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 the latest compliance standards will help you shine during those crucial conversations.
✨Tip Number 3
Showcase your experience with batch certification and release in your discussions. We want to hear about your hands-on experience as a Qualified Person, so be ready to share specific examples that highlight your expertise and leadership in quality assurance.
✨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 take the initiative to connect directly with us.
We think you need these skills to ace Qualified Person in Warrington
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Qualified Person role. Highlight your experience in batch certification, sterile manufacturing, and any relevant qualifications. 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: Don’t forget to highlight your technical skills related to GMP, Annex 16, and quality assurance processes. We’re looking for someone who can hit the ground running, so make sure we see your expertise clearly!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep everything organised and ensures your application gets the attention it deserves. We can’t wait to hear from you!
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 or challenges you've faced will show that you're not just familiar with the theory but can apply it in practice.
✨Showcase Your QA Leadership Skills
Prepare examples that highlight your experience in providing QA leadership across sterile manufacturing. Think about times when you’ve led a team through audits or inspections, and be ready to discuss how you ensured compliance and quality throughout the process.
✨Be Ready for Technical Questions
Expect technical questions related to batch certification and release processes. Brush up on your understanding of manufacturing data review, APQRs, and CAPA. Practising these concepts will help you articulate your thought process clearly during the interview.
✨Demonstrate Continuous Improvement Mindset
If you have experience with Lean/Six Sigma, be prepared to discuss how you've implemented these methodologies in your previous roles. Companies love candidates who are proactive about improving processes, so share specific examples of how you've driven quality improvements.
