Job Title: Pharmaceutical Quality Engineer (Contract - Outside IR35) Cheshire
Location: Onsite
Contract Length: 6-12 months (with potential extension)
Day Rate: Competitive (Outside IR35
Overview
We are seeking an experienced Pharmaceutical Quality Engineer to support quality assurance and compliance activities within a regulated manufacturing environment. This is a contract role operating outside IR35, suited to a professional with a strong background in GMP and a proactive, detail-oriented approach to quality engineering.
Key Responsibilities
*Provide quality engineering support across manufacturing, validation, and supply chain operations
*Ensure compliance with GMP, GDP, and relevant regulatory standards
*Lead and support deviation investigations, CAPA management, and root cause analysis
*Review and approve quality documentation including SOPs, batch records, and validation protocols
*Support internal and external audits, including regulatory inspections
*Collaborate cross-functionally with production, QC, validation, and engineering teams
*Drive continuous improvement initiatives to enhance quality systems and processes
*Assist with change control processes and risk assessments
Requirements
*Proven experience in a Quality Engineering or Quality Assurance role within the pharmaceutical or life sciences industry
*Strong working knowledge of GMP regulations and quality systems
*Experience with deviation handling, CAPA, and audit support
*Familiarity with validation processes (IQ/OQ/PQ) is desirable
*Excellent problem-solving and analytical skills
*Strong communication and stakeholder management abilities
*Ability to work independently in a fast-paced contract environment
Desirable Skills
*Experience with regulatory bodies such as MHRA, FDA, or EMA
*Background in sterile manufacturing, biologics, or medical devices
*Six Sigma / Lean certification (or similar continuous improvement methodologies)
Additional Information
*Outside IR35 determination confirmed
*Flexible working arrangements may be available depending on project needs
*Immediate or short-notice availability preferred