Pharmaceutical Quality Engineer (Contract, Outside IR35)

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