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 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