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We are currently recruiting for a Quality Assurance Officer to join a fast-paced pharmaceutical manufacturing organisation committed to delivering high-quality, safe, and compliant products including unlicensed medicines and NHS-approved disinfectants.

This is a key role within the QHSE department, supporting the ongoing development and maintenance of a robust Quality Management System (QMS) in line with GMP, ISO 9001, and ISO 14001 standards.

About the Role

As a Quality Assurance Officer, you will play a critical role in ensuring product quality, regulatory compliance, and continuous improvement across the site. You will work closely with cross-functional teams including production, QC, and technical departments to maintain high standards of compliance and operational excellence.

You will be involved in document control, deviation management, CAPA systems, internal audits, and regulatory inspection support, helping to drive a strong culture of quality and accountability.

Key ResponsibilitiesSupport the maintenance and continuous improvement of the Quality Management System (QMS)Review, author, and update SOPs, specifications, and controlled documentsManage deviations, CAPAs, change controls, OOS/OOT investigations, complaints, and recallsSupport and participate in internal and external auditsAssist in preparation for regulatory inspections (e.g. MHRA, ISO audits)Maintain training records and site-wide training matricesSupport quality metrics, KPI reporting, and trend analysisEnsure accurate document control, archiving, and compliance systemsContribute to continuous improvement initiatives across the business EssentialA degree in a scientific or related discipline, or equivalent relevant industry experienceStrong working knowledge of Good Manufacturing Practice (GMP) within a regulated environmentHands-on experience with Quality Management Systems (QMS)Practical experience in key QA processes including document control, deviations, CAPA, and change controlExperience supporting or preparing for internal and external audits / regulatory inspectionsDesirable ExperienceISO 9001 / ISO 14001 exposureInternal auditing experienceGMP/QMS auditing certification

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Are you a detail‑driven Quality professional ready to advance your career in pharmaceutical manufacturing? Smart4 Sciences has partnered with a leading pharmaceutical company based in Knutsford, to recruit a Quality Assurance Officer for their QHSE team.

In this role, you'll collaborate across departments to ensure full compliance with GMP, ISO9001, and ISO14001 standards. You'll be central to maintaining the Quality Management System (QMS), supporting audits, and driving continuous improvement, while ensuring documentation and processes consistently meet regulatory requirements.

Key Responsibilities

Generate and review SOPs and quality documentation

Maintain training records and site‑wide training matrix

Execute and oversee QMS activities including risk assessments, change controls, CAPAs, deviations, complaints, recalls, and OOS/OOT

Participate in internal audits and support external regulatory inspections

Manage document control, archiving, and quality metric reporting

Provide QA expertise to cross‑functional teams and contribute to quality improvement initiatives

What We're Looking For

Around 5 years' QA experience in pharmaceuticals or related industry

Strong knowledge of GMP and compliance standards

Experience in QMS processes, document control, and audit support

Exceptional attention to detail, organisation, and problem‑solving skills

Confident communicator with clear written and verbal ability

Proficiency in Microsoft Office and SharePoint

Personal Attributes

Accurate, efficient, and adaptable

Strong team player with a collaborative mindset

Professional, resilient, and committed to continuous improvement

High ethical standards and integrity

If this sounds like the right opportunity for you, apply today or get in touch for a confidential conversation.

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