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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 pharmaceutical or medical device environments.
- Other info: Collaborate with a skilled QA team and gain 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 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 Engage
Contact Detail:
Inizio Engage 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. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its values. Understand their compliance processes and be ready to discuss how your experience aligns with their needs. We want you to shine!
✨Tip Number 3
Practice common interview questions, especially those related to quality assurance and compliance. Mock interviews with friends or mentors can help you feel more confident and articulate your thoughts clearly.
✨Tip Number 4
Don’t forget to follow up after interviews! A quick thank-you email can leave a lasting impression and show your enthusiasm for the role. Plus, it keeps you on their radar as they make their decision.
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 how you've maintained compliance and improved processes in previous roles.
Showcase Your Attention to Detail: As a Quality Officer, attention to detail is key. In your application, make sure to demonstrate this by being clear and concise. Avoid typos and ensure your documents are well-organised – it reflects your commitment to quality!
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of success. It streamlines the process for us and ensures your application gets the attention it deserves. Don’t miss out on this opportunity!
How to prepare for a job interview at Inizio Engage
✨Know Your Regulations
Familiarise yourself with GMP, ISO 13485, and 21 CFR regulations. Being able to discuss these in detail will show your understanding of the compliance landscape and how it applies to the role.
✨Prepare for Scenario Questions
Expect questions about handling quality incidents or deviations. Think of specific examples from your past experience where you successfully managed such situations, as this will demonstrate your problem-solving skills.
✨Showcase Your Attention to Detail
As a Quality Officer, attention to detail is crucial. Be ready to discuss how you ensure accuracy in your work, whether it's through reviewing SOPs or conducting audits. Highlight any tools or methods you use to maintain high standards.
✨Engage with the Team Dynamics
Since this role involves significant interaction with various teams, be prepared to talk about your collaborative experiences. Share how you've worked with manufacturing, microbiology, or clients to achieve compliance and quality goals.
