What You’ll Be Responsible For

GMP Quality System Support

• Support the maintenance and effective operation of the site Quality Management System (QMS)
• Ensure compliance with GMP, Data Integrity, and internal quality standards
• Support quality activities across a regulated manufacturing environment

Document Control & Quality Administration

• Act as part of the site document control function, managing:
  • SOPs, policies, and controlled documents
  • Manufacturing and batch documentation
• Ensure documents are issued, maintained, and archived in line with QMS requirements

Change Control, Trending & Quality Metrics

• Support the administration of change control processes, with a clear understanding of how changes impact GMP systems
• Maintain oversight of quality metrics and KPIs, including trend analysis and reporting
• Support continuous improvement through data-driven quality insights

Supplier & Audit Support

• Support qualification and approval of GMP-compliant suppliers
• Maintain supplier quality documentation and records
• Support internal and external audits through preparation, participation, and follow-up activities

General Quality Support

• Support logging and management of risk assessments, calibration, qualification, and validation documentation
• Provide day-to-day quality support to GMP operations and quality specialists

About You

You are a quality professional with hands-on experience in GMP environments, comfortable working within established quality systems and supporting their day-to-day operation.

You’ll bring:

• Experience working in a GMP-regulated environment
• Practical understanding of Quality Management Systems
• Awareness of change control processes and quality governance
• Strong document management and organisational skills
• Confidence working on-site alongside operational teams

Desirable (but not essential):

• Experience working with GMP suppliers and supplier qualification
• Exposure to quality metrics, KPI trending, or review processes
• Background in quality, QC, or technical operations within regulated manufacturing

This role does not require extensive QA leadership experience — QMS exposure and GMP understanding are the key requirements.