Quality Officer - Compliance & Process Support (Quality Assurance)
Leicester | Sterile Manufacturing
15-month Fixed Term Contract | Full time (37 hours/week) | Immediate Start
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.
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