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- Tasks: Ensure compliance and quality excellence in sterile manufacturing processes.
- Company: Join a leading pharmaceutical company focused on patient safety.
- Benefits: Gain valuable experience, competitive salary, and professional development opportunities.
- Why this job: Make a real impact on product quality and patient safety in a dynamic environment.
- Qualifications: Science-based degree and experience in regulated environments required.
- Other info: Be part of a skilled QA team with exposure to audits and inspections.
The predicted salary is between 36000 - 60000 £ per year.
Inizio Engage has an exciting opportunity for a Quality Officer – Compliance & Process Support to join our Client's Quality Assurance team, supporting our Sterile Manufacturing facilities.
Reporting to the Principal Quality Officer – Compliance and Process Support, you will act as the primary QA liaison for sterile manufacture of marketed and investigational medicinal products, playing a key role in maintaining regulatory compliance and quality excellence.
About the role
You will work closely with Sterile Manufacturing to ensure ongoing compliance with GMP, ISO 13485, 21 CFR, Medicines Regulations, and internal procedures. This is a highly visible role with significant interaction across manufacturing, microbiology, clients, and auditors.
Key responsibilities include:
- Managing Quality Systems and GMP compliance within Sterile Manufacturing
- Investigation and review of Quality Incidents, Deviations, OOS results, and Customer Complaints
- Performing regular Gemba walks across manufacturing areas
- Supporting microbiology investigations
- Tracking and closing CAPAs and effectiveness checks
- Instigating, reviewing, and approving Change Controls
- Planning, performing, and closing out internal audits
- Delivering and coordinating training sessions
- Reviewing and updating SOPs
- QA review of Batch Manufacturing & Packaging Records and Aseptic Process Simulations
About you
You are a detail-oriented QA professional with experience in regulated pharmaceutical or medical device environments.
Essential:
- Science-based degree
- Experience working with aseptically manufactured pharmaceuticals or medical devices
- Strong working knowledge of ISO 13485
- Good understanding of EudraLex Volume 4, Medicines Regulations (as amended), and 21 CFR
- Proficiency in Microsoft Office and electronic QMS (e.g. Q-Pulse, TrackWise)
Why join our Client?
- Be part of a highly skilled QA team in a regulated sterile manufacturing environment
- Gain exposure to client audits, regulatory inspections, and new product introductions
- Develop your QA expertise across pharmaceuticals and medical devices
- Make a real impact on patient safety and product quality
How to apply
Interested? Apply now! Please note if you have not heard from Recruitment within 7 days of submitting your application, your application has been unsuccessful.
Quality Assurance Specialist in Loughborough employer: Inizio Engage
Contact Detail:
Inizio Engage Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Specialist in Loughborough
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those working in Quality Assurance. Attend events or webinars related to sterile manufacturing and connect with professionals on LinkedIn. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP, ISO 13485, and relevant regulations. We recommend creating a cheat sheet of key concepts and examples from your experience that demonstrate your expertise. This will help you stand out during the interview process.
✨Tip Number 3
Showcase your skills through practical examples. When discussing your experience, highlight specific instances where you managed quality systems or resolved compliance issues. This will give potential employers a clear picture of what you can bring to their team.
✨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 about their job search. So, get your application in and let’s make it happen!
We think you need these skills to ace Quality Assurance Specialist in Loughborough
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Assurance role. Highlight your experience with GMP, ISO 13485, and any relevant quality systems you've worked with. 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 passionate about quality assurance and how your skills can contribute to our team. Keep it concise but impactful – we love a good story!
Showcase Relevant Experience: When filling out your application, be sure to showcase your experience in regulated environments, especially with aseptically manufactured products. We’re keen on seeing how you’ve tackled challenges in previous roles.
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’s super easy – just follow the prompts!
How to prepare for a job interview at Inizio Engage
✨Know Your Regulations
Familiarise yourself with GMP, ISO 13485, and 21 CFR regulations. Be ready to discuss how your experience aligns with these standards, as this role heavily focuses on compliance.
✨Showcase Your Detail Orientation
Prepare examples that highlight your attention to detail, especially in managing quality systems and handling deviations or complaints. Use specific instances from your past roles to illustrate your capabilities.
✨Engage with the Team
Since this position involves significant interaction across various departments, practice how you would communicate effectively with manufacturing, microbiology, and auditors. Think of questions to ask that show your interest in collaboration.
✨Prepare for Scenario Questions
Expect scenario-based questions related to quality incidents or CAPA tracking. Prepare to walk through your thought process and decision-making steps in these situations, demonstrating your problem-solving skills.
