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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: Eligible Qualified Person with experience in sterile manufacturing and QA.
- 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 Wrexham employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualified Person in Wrexham
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharmaceutical industry, especially those who work in Quality Assurance. Attend industry events or webinars to make connections and learn about potential job openings.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of UK and EU GMP regulations. Be ready to discuss your experience with batch certification and how you've ensured compliance in previous roles.
✨Tip Number 3
Showcase your leadership skills! When discussing your past experiences, highlight instances where you provided QA leadership or oversaw manufacturing operations. This will demonstrate your capability as a Qualified Person.
✨Tip Number 4
Don't forget to apply through our website! We often have exclusive listings that might not be found elsewhere. Plus, it’s a great way to ensure your application gets noticed by the right people.
We think you need these skills to ace Qualified Person in Wrexham
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 quality assurance and regulatory compliance. If you've got experience with Lean/Six Sigma or Lead Auditor certification, make sure to highlight that. We love seeing those details!
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss out on any important updates. 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. Be prepared to discuss how you've applied these standards in your previous roles, particularly in batch certification and release.
✨Showcase Your QA Leadership Skills
Think of specific examples where you've provided QA leadership in sterile manufacturing. Highlight your experience with internal audits and regulatory inspections, as this will demonstrate your capability to oversee compliance effectively.
✨Prepare for Technical Questions
Expect technical questions related to quality review processes, APQRs, and CAPA. Practise explaining your approach to these areas clearly and concisely, as it shows your depth of knowledge and problem-solving skills.
✨Demonstrate Your Commitment to Quality
Be ready to discuss how you’ve fostered a culture of quality in your previous positions. Share examples of how you've supported continuous improvement initiatives, like Lean/Six Sigma, to show that you’re proactive about maintaining high standards.
