Quality Assurance Specialist

CompanyInizio Engage

LocationLeicester, England, United Kingdom

Posted At1/14/2026

UK Visa Sponsorship Analytics

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Occupation Type

Quality assurance and regulatory professionals

Occupation Code Skill LevelHigher Skilled

Sponsorship Salary Threshold

£48,200 (£24.72 per hour)

Occupation rate applies

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Description

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.

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.