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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 assurance.
- 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: Opportunity for growth in a supportive and innovative 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.
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 Birkenhead employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualified Person in Birkenhead
✨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 these areas will help you shine when discussing your experience as a Qualified Person.
✨Tip Number 3
Showcase your leadership skills! When talking about your past roles, highlight how you've provided QA leadership and ensured compliance in sterile manufacturing. This will demonstrate your capability to take charge in a new role.
✨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 are proactive and engaged with our platform.
We think you need these skills to ace Qualified Person in Birkenhead
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, GMP compliance, and any relevant qualifications. We want to see how your background aligns 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 the role. Share specific examples of your QA leadership and sterile manufacturing experience. Let us know what makes you tick!
Showcase Your Technical Skills: Don’t forget to mention your technical skills related to the job description. If you've got experience with Lean/Six Sigma or Lead Auditor certification, make sure to highlight that. We love seeing candidates who are well-rounded!
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 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 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 in those situations.
✨Be Ready for Technical Questions
Expect technical questions related to batch certification and release processes. Brush up on your knowledge of manufacturing data review, APQRs, and CAPA. Practising answers to common technical queries can help you feel more confident during the interview.
✨Demonstrate Your 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.
