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- Tasks: Certify sterile products and ensure compliance with EU GMP regulations.
- Company: Forward-thinking pharmaceutical company in Sheffield focused on patient safety.
- Benefits: Competitive salary, supportive team, and hands-on experience in a vital role.
- Why this job: Make a real impact in sterile manufacturing and enhance patient safety.
- Qualifications: Qualified Person status and experience in certifying sterile products required.
- Other info: Fully site-based role with opportunities for professional growth.
The predicted salary is between 36000 - 60000 £ per year.
Are you a Qualified Person ready to make a real impact in sterile manufacturing?
Whether you\’re newly qualified or bring years of experience, this is a fantastic opportunity to join a forward-thinking pharmaceutical company based in Sheffield.
You\’ll play a vital role in ensuring the safety, quality, and compliance of sterile medicinal products, supporting a business that places patient safety and regulatory excellence at the heart of its operations.
What You\’ll Be Doing
- Certifying batches of sterile products in line with EU GMP and regulatory requirements.
- Reviewing batch documentation, analytical results, and deviation reports to ensure product integrity.
- Leading and supporting investigations into quality issues and implementing effective CAPAs.
- Participating in internal and external audits, contributing to the continuous improvement of the Quality Management System.
- Providing expert advice to cross-functional teams on quality standards and compliance expectations.
Who We\’re Looking For
- A Qualified Person eligible under UK regulations, with full QP status.
- Experience certifying sterile products is essential – this could come from clinical, commercial, or aseptic manufacturing environments.
- A solid background in pharmaceutical QA and manufacturing, ideally within sterile operations.
- Proven experience working with Quality Management Systems and regulatory frameworks.
- A relevant scientific degree (Pharmacy, Chemistry, Biology, or similar).
- Strong communication, problem-solving, and decision-making skills.
Whether you\’re stepping into your first QP role or bringing years of insight, you\’ll be supported by a collaborative, quality-driven team in a hands-on environment.
Please note: This is a
fully site-based
role and remote or hybrid working is not available.
Qualified Person employer: AssureBio
Contact Detail:
AssureBio 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 sterile manufacturing. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU GMP and regulatory requirements. We want you to showcase your expertise in certifying sterile products and handling quality issues confidently.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation and reiterate your enthusiasm for the role. It keeps you fresh in their minds!
✨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 engaged with our company.
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 certifying sterile products and any relevant QA background. We want to see how your skills match 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 passionate about ensuring patient safety and compliance. Share specific examples of your past experiences that relate to the job description.
Showcase Your Qualifications: Don’t forget to mention your full QP status and relevant scientific degree. We’re keen on seeing how your qualifications align with our needs, so make them stand out in your application!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from our team!
How to prepare for a job interview at AssureBio
✨Know Your Regulations
Make sure you brush up on EU GMP and other relevant regulatory requirements before the interview. Being able to discuss these confidently will show that you’re not just qualified, but also genuinely engaged with the industry standards.
✨Prepare for Scenario Questions
Expect questions about how you would handle specific quality issues or deviations. Think of examples from your past experience where you successfully led investigations or implemented CAPAs, as this will demonstrate your problem-solving skills.
✨Showcase Your Team Spirit
Since the role involves working with cross-functional teams, be ready to share examples of how you've collaborated with others in the past. Highlighting your communication skills and ability to provide expert advice will make you stand out.
✨Ask Insightful Questions
Prepare a few thoughtful questions about the company’s approach to quality management and continuous improvement. This shows your interest in their operations and helps you assess if it’s the right fit for you.
