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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 operationsEnsure compliance with GMP, GDP, and relevant regulatory standardsLead and support deviation investigations, CAPA management, and root cause analysisReview and approve quality documentation including SOPs, batch records, and validation protocolsSupport internal and external audits, including regulatory inspectionsCollaborate cross-functionally with production, QC, validation, and engineering teamsDrive continuous improvement initiatives to enhance quality systems and processesAssist with change control processes and risk assessments

Requirements

Proven experience in a Quality Engineering or Quality Assurance role within the pharmaceutical or life sciences industryStrong working knowledge of GMP regulations and quality systemsExperience with deviation handling, CAPA, and audit supportFamiliarity with validation processes (IQ/OQ/PQ) is desirableExcellent problem-solving and analytical skillsStrong communication and stakeholder management abilitiesAbility to work independently in a fast-paced contract environment

Desirable Skills

Experience with regulatory bodies such as MHRA, FDA, or EMABackground in sterile manufacturing, biologics, or medical devicesSix Sigma / Lean certification (or similar continuous improvement methodologies)

Additional Information

Outside IR35 determination confirmedFlexible working arrangements may be available depending on project needsImmediate or short-notice availability preferred Read less