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.
- 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 Coventry employer: Inizio Engage
Contact Detail:
Inizio Engage Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Specialist in Coventry
✨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 products. Understand their quality assurance processes and be ready to discuss how your experience aligns with their needs. Show them you’re not just another candidate!
✨Tip Number 3
Practice common interview questions, especially those related to quality assurance and compliance. Use the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your achievements.
✨Tip Number 4
Don’t forget to follow up after your interview! 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 Assurance Specialist in Coventry
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in quality assurance and compliance, especially in sterile manufacturing. We want to see how your background aligns with the role, so don’t be shy about showcasing relevant skills and achievements!
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 expertise can contribute to our team. Keep it concise but impactful – we love a good story!
Showcase Your Attention to Detail: As a QA professional, attention to detail is key. Make sure your application is free from typos and errors. We appreciate candidates who take the time to present their best selves, so double-check everything before hitting send!
Apply Through Our Website: We encourage you to apply directly through our website for a smoother process. It’s the best way to ensure your application gets into the right hands quickly. Plus, it shows us you’re keen on joining our team!
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 role involves significant interaction across various departments, practice how you would communicate with manufacturing, microbiology, and auditors. Think about how you can demonstrate teamwork and collaboration during the interview.
✨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.
