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 assessmentsRequirements
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 environmentDesirable 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
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