Quality Consultant

Walker Cole International is supporting a UK-based life sciences organisation in the appointment of a Quality Assurance / Quality Systems Specialist (Contract). This role will support the ongoing maintenance and continuous improvement of the Quality Management System within a highly regulated GMP environment, ensuring compliance with regulatory requirements and maintaining inspection readiness. The position will play a key role in supporting the QA team through day-to-day quality system activities, environmental monitoring oversight and audit readiness.

Key Responsibilities

• Lead investigations, risk assessments and concessions, ensuring timely resolution of quality issues
• Generate and maintain testing guides, specifications and material requirements within the QMS
• Support batch release activities and generate Certificates of Analysis (CoAs)
• Liaise with suppliers regarding documentation gaps and out of specification results
• Collaborate cross-functionally on material assessments and manufacturing planning
• Create and update SOPs, work instructions and testing libraries (FTIR/NIR)
• Maintain audit readiness and support internal and external audits (ISO9001 & cGMP)

Required Experience and Skills

Experience working within GMP regulated pharmaceutical or aseptic manufacturing environments
Understanding of Quality Management Systems and inspection readiness activities
Experience supporting audits, CAPAs, deviations and investigations
Strong documentation and data management skills
Ability to work cross-functionally across Quality and Operations teams

Working Pattern

On-site (UK)

Contract Length

3-6 months

Location

United Kingdom

Keywords

Quality Assurance | GMP | QMS | Environmental Monitoring | CAPA | Deviations | Radiopharmaceuticals | Aseptic Manufacturing | Contract