Quality Officer – Compliance & Process Support (Quality Assurance)
Leicester | Sterile Manufacturing
15-Month Fixed Term Contract | 37 hours per week | Immediate Start
Are you a detail-driven QA professional ready to make a real impact in sterile manufacturing?
Inizio Engage is partnering with a leading organisation to recruit a Quality Officer – Compliance & Process Support to join a high-performing Quality Assurance team. This is an exciting opportunity to play a pivotal role in safeguarding patient safety while working at the forefront of sterile pharmaceutical and medical device manufacturing.
Reporting to the Principal Quality Officer, you will act as the primary QA liaison for the manufacture of both marketed and investigational medicinal products. This is a visible, hands-on position where your expertise will directly support compliance, quality excellence, and continuous improvement across the sterile manufacturing operation.
What You’ll Be Doing
In this varied and impactful role, you will:
- Lead GMP and Quality Systems compliance within Sterile Manufacturing
- Investigate and review deviations, quality incidents, OOS results, and customer complaints
- Conduct regular Gemba walks across manufacturing areas
- Support microbiological investigations
- Drive CAPA tracking, closure, and effectiveness checks
- Initiate, review, and approve Change Controls
- Plan, perform, and close internal audits
- Deliver and coordinate GMP and quality training
- Review and update SOPs
- Perform QA review of Batch Manufacturing & Packaging Records and Aseptic Process Simulations
You’ll collaborate closely with Manufacturing, Microbiology, Clients, and Auditors — giving you broad exposure across technical, operational, and regulatory functions.
About You
You are a proactive and quality-focused professional who thrives in regulated environments and enjoys working cross-functionally to uphold high standards.
Essential Requirements:
- Science-based degree
- Experience within aseptic pharmaceutical or medical device manufacturing
- Strong working knowledge of ISO 13485
- Good understanding of EudraLex Volume 4, Medicines Regulations (as amended), and 21 CFR
- Experience using electronic QMS systems (e.g., Q-Pulse, TrackWise)
- Strong organisational skills with excellent attention to detail
Why This Role?
- Join a highly skilled QA team within a sterile manufacturing environment
- Gain exposure to regulatory inspections and client audits
- Broaden your experience across pharmaceuticals and medical devices
- Contribute directly to patient safety and product quality
- Work in a collaborative, quality-driven culture
If you are ready to take the next step in your QA career and want to be part of a team that truly values quality excellence, we’d love to hear from you.
Apply today.
Please note: If you have not heard from the Recruitment team within 7 days of your application, unfortunately your application has not been successful on this occasion.