Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- 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.
- Other info: Immediate start with a chance to work closely with a skilled QA team.
- 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 pharmaceutical or medical device environments.
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 Nova Laboratories?
- 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 Officer- Compliance & Process Support in Leicester employer: Inizio
Contact Detail:
Inizio Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Officer- Compliance & Process Support in Leicester
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that Quality Officer role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP, ISO 13485, and relevant regulations. We suggest doing mock interviews with friends or using online resources to get comfortable discussing your experience and how it relates to the job.
✨Tip Number 3
Showcase your passion for quality assurance! During interviews, share specific examples of how you've contributed to compliance and process improvements in past roles. We want to see your enthusiasm for maintaining regulatory standards.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for talented individuals to join our team, so make sure you put your best foot forward!
We think you need these skills to ace Quality Officer- Compliance & Process Support in Leicester
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Officer 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 our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance in sterile manufacturing. Share specific examples of your past experiences that relate to the responsibilities listed in the job description.
Showcase Your Attention to Detail: As a Quality Officer, attention to detail is key. In your application, make sure to proofread for any typos or errors. A clean, well-organised application reflects the quality we value at StudySmarter.
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’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at Inizio
✨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 role involves significant interaction across various departments, practice how you would communicate effectively with manufacturing, microbiology, and auditors. Think about how you can demonstrate teamwork and collaboration.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific quality incidents or audits. Prepare by thinking through potential scenarios and your approach to resolving them, showcasing your problem-solving skills.