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- Tasks: Ensure compliance with quality standards in sterile manufacturing and support QA processes.
- Company: Join a leading pharmaceutical company focused on patient safety and product quality.
- Benefits: Gain valuable experience, develop your skills, and work in a dynamic team environment.
- Why this job: Make a real impact on healthcare while growing your expertise in quality assurance.
- Qualifications: Science-based degree and experience in regulated environments required.
- Other info: Immediate start with opportunities for professional development.
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.
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 Officer- Compliance & Process Support in London 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 London
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those working in Quality Assurance. 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 GMP and ISO 13485. We recommend practising common interview questions related to compliance and quality systems to show you're the right fit.
✨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 interest in the role. It keeps you fresh in their minds.
✨Tip Number 4
Apply through our website for the best chance at landing that Quality Officer role! We’re always on the lookout for passionate candidates who want to make a difference in patient safety and product quality.
We think you need these skills to ace Quality Officer- Compliance & Process Support in London
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 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 detailing your experience, focus on specific examples that demonstrate your knowledge of compliance and process support in sterile manufacturing. We’re keen to see 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 makes the whole process smoother for everyone involved.
How to prepare for a job interview at Inizio Engage
✨Know Your Regulations
Make sure you brush up on GMP, ISO 13485, and 21 CFR before the interview. Being able to discuss these regulations confidently will show that you understand the compliance landscape and are ready to hit the ground running.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've managed quality systems or dealt with quality incidents. Use the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your problem-solving skills.
✨Ask Insightful Questions
Come prepared with questions about the company's quality assurance processes and how they handle audits and compliance. This not only shows your interest in the role but also gives you a chance to assess if the company aligns with your values.
✨Demonstrate Team Collaboration
Since this role involves significant interaction with various teams, be ready to discuss how you've successfully collaborated with others in the past. Highlight any training sessions you've delivered or how you've supported cross-functional teams in achieving compliance.