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QA Officer About the Role

Smart4 Sciences is partnering with a leading pharmaceutical company to recruit a QA Officer - Validation & Compliance. This is an excellent opportunity for someone with experience in pharmaceutical Quality Assurance who enjoys working across validation, compliance, technology transfer, and new product introduction activities.

Working within a GMP-regulated environment, you will play a key role in ensuring third-party manufacturers and laboratories remain compliant with regulatory requirements and registered dossiers while supporting the successful delivery of new product projects and ongoing quality initiatives.

Key Responsibilities

Support new product development, technology transfers, and new product introductions from a Quality Assurance perspective.

Coordinate and participate in project meetings with internal stakeholders and external manufacturing and testing partners.

Review and approve analytical method validation, verification, and transfer protocols and reports.

Review manufacturing and packaging process validation protocols and reports.

Review Master Batch Manufacturing and Packaging Records, finished product specifications, methods of analysis, shelf-life specifications, and stability protocols.

Evaluate technical documentation provided by Contract Manufacturing Organisations (CMOs) and Contract Testing Laboratories (CTLs).

Assess Quality Management System documentation including Change Controls, Deviations, Out of Specification (OOS) investigations, CAPAs, and associated quality records.

Maintain and update the Validation Master Plan to ensure ongoing compliance.

Support investigations, market complaints, SOP updates, and continuous improvement activities.

Contribute to site KPIs, product quality objectives, and Health, Safety & Environmental (HSE) standards.

Build strong working relationships with internal departments including Regulatory Affairs, Supply Chain, Logistics, and Sales, as well as external CMOs and CTLs.

About You

We're looking for someone who has:

Experience within Pharmaceutical Quality Assurance in a GMP-regulated environment.

Knowledge of validation principles, including analytical method validation and process validation.

Experience reviewing validation documentation, batch records, technical reports, and quality documentation.

Good understanding of Change Control, CAPA, Deviations, OOS investigations, and Quality Management Systems.

Familiarity with technology transfer and new product introduction activities would be advantageous.

Excellent attention to detail with strong document review skills.

Strong communication and stakeholder management skills.

The ability to manage multiple priorities while meeting project deadlines.

A degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences, or a related scientific discipline is desirable.

What's on Offer

Opportunity to work on exciting new product and technology transfer projects.

Exposure to cross-functional teams and external manufacturing partners.

Career development within a growing pharmaceutical quality function.

Supportive and collaborative working environment.

Competitive salary and benefits package.

If you're passionate about pharmaceutical quality, validation, and compliance and want to play a key role in delivering high-quality products to market, we'd love to hear from you. Apply today!

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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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Document Manager - CAPEX Projects (Pharmaceutical Industry) Contract, Outside IR35

We are seeking an experienced and detail-oriented Document Manager to support CAPEX (Capital Expenditure) projects within a dynamic pharmaceutical environment. This role is critical in ensuring the effective control, organization, and compliance of project documentation across all phases of delivery.

Key Responsibilities:

Establish and maintain document control systems for CAPEX projects, ensuring accuracy, version control, and accessibility.Manage the lifecycle of engineering, construction, and validation documents in line with regulatory and company standards.Coordinate with project managers, engineers, contractors, and quality teams to ensure timely submission, review, and approval of documents.Ensure compliance with industry regulations (e.g GMP) and internal quality management systems.Track document status, generate reports, and support audits and inspections.Implement and improve document management processes and tools to enhance efficiency.

Key Requirements:

Proven experience in document control or document management within pharmaceutical, life sciences, or highly regulated industries.Familiarity with CAPEX project environments (engineering, construction, commissioning).Strong understanding of document control systems and electronic document management systems (EDMS).Knowledge of regulatory requirements such as GMP and data integrity principles.Excellent organizational, communication, and stakeholder management skills.High attention to detail and ability to manage multiple priorities under tight deadlines.

Desirable:

Experience supporting large-scale pharmaceutical or biotech facility projects.Familiarity with validation documentation (IQ/OQ/PQ) and quality systems.Degree or relevant qualification in a technical or business-related discipline.

What We Offer:

Opportunity to work on high-impact CAPEX projects in a regulated, innovative industry.Collaborative and professional work environment.Competitive salary and benefits package.

If you are a proactive and structured professional with a passion for document excellence in complex project environments, we would like to hear from you.

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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

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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