Pharmaceutical Quality Engineer

Smart4Sciences
Cheshire, United Kingdom
2 weeks ago
Job Type
Contract
Work Pattern
Flexible
Work Location
On-site
Seniority
Mid
Education
Degree
IR35 Status
Outside
Posted
1 May 2026 (2 weeks ago)

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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