Pharmaceutical Quality Engineer (Contract, Outside IR35)
Posted Today by Smart4Sciences
Negotiable
Outside
Onsite
Cheshire
Summary: The Pharmaceutical Quality Engineer role is a contract position based in Cheshire, focused on supporting quality assurance and compliance in a regulated manufacturing environment. The ideal candidate will have a strong background in GMP and will be responsible for various quality engineering tasks, including deviation investigations and audit support. This role operates outside IR35 and is suited for a proactive professional with a detail-oriented approach. The contract length is between 6 to 12 months, with potential for extension.
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
Key Skills:
- 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
Salary (Rate): undetermined
City: Cheshire
Country: undetermined
Working Arrangements: on-site
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: Other
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