Quality Officer- Compliance & Process Support

Inizio Engage; Leicester; On-site; GBP 35,000 - 48,000; Full time

Benefits offered by this job

Health insurance

Job summary

Inizio Engage's client seeks a Quality Officer to support Compliance & Process in a sterile manufacturing facility in Leicester. You will manage GMP compliance, assist with deviations, CAPAs, changes, and internal audits, contributing to patient safety and product quality.

Ideal candidates have a science-based degree and hands-on experience in aseptic pharma or medical devices, with ISO 13485 and relevant regulations. The role offers an immediate start on a 15-month contract.

Qualifications

• Experience in regulated pharmaceutical or medical device environments.
• Knowledge of ISO 13485 and Medicines Regulations.
• Experience with aseptically manufactured products.
• Proficiency with MS Office and electronic QMS systems.

Responsibilities

• Manage Quality Systems and GMP compliance within Sterile Manufacturing.
• Investigate and review Quality Incidents, Deviations, OOS results, and Customer Complaints.
• Perform regular Gemba walks across manufacturing areas.
• Support microbiology investigations.
• Track and close CAPAs and effectiveness checks.
• Review and approve Change Controls.
• Plan, perform, and close internal audits.
• Deliver and coordinate training sessions.
• Review SOPs and QA reviews of Batch Manufacturing, Packaging Records, and Aseptic Process Simulations.

Skills

Quality Assurance

GMP Compliance

Regulatory Knowledge

Documentation Control

Education

Science degree

Tools

Q-Pulse

TrackWise

Job 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.

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.

• 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