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Quality Manager - Cwmbran (Near Newport, South Wales)

A leading CRO is looking for a Quality Manager to join its Cwmbran team, taking ownership of day‑to‑day Quality Assurance operations and ensuring both GMP and non‑GMP activities meet the highest standards of compliance, integrity, and client commitment.

In this pivotal role, you'll provide hands‑on QA leadership across the full spectrum of quality system activities - from laboratory oversight and supplier audits to inspection readiness and documentation review. You'll be expected to apply pragmatic, risk‑based judgement suited to a dynamic contract laboratory environment where regulated and non‑regulated activities coexist.

As a senior quality practitioner and people manager, you'll guide operational teams, coach staff on GMP and non‑GMP expectations, and step in to deputise for the Head of Quality when required. This is a role for someone who thrives on responsibility, collaboration, and driving a culture of compliance and continuous improvement.

Key Responsibilities

Provide routine QA oversight of GMP and non‑GMP laboratory activities

Maintain and improve the Pharmaceutical Quality System (PQS), including deviations, CAPAs, change controls, and investigations

Arrange, host, and respond to client audits and regulatory inspections

Lead, perform, and report on internal audits in line with the site audit programme

Conduct supplier audits, oversee supplier qualification, and maintain the Approved Supplier List

Apply data integrity and CSV principles across GxP systems

Support or lead implementation of electronic Quality Management Systems (eQMS)

Line‑manage 2 QA direct reports and mentor up to 4 indirect reports

Identify training needs, coach staff, and promote a strong quality culture

Drive continuous improvement initiatives across QA processes and systems

What We're Looking For

Significant QA experience within a GMP‑regulated environment

Experience in a contract laboratory or service‑based organisation conducting GMP and non‑GMP activities

Demonstrable experience conducting internal and supplier audits

Proven track record supporting and hosting client and regulatory inspections

Strong working knowledge of EU GMP, FDA CFRs, Annex 11, and ICH Q8-Q10

Sound understanding of data integrity and CSV principles

Approachable, credible, and collaborative leadership style

Confident communicator with internal stakeholders, clients, and regulators

Practical, solution‑focused, and calm under inspection conditions

Desirable:

Experience implementing or enhancing electronic Quality Management Systems (eQMS)

QMS Lead Auditor qualification

Certified training within GxP

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Development Chemist

Household & Consumer Products | Redditch

An established and growing manufacturer within the consumer products sector is looking to appoint an experienced Development Chemist to support the creation and improvement of a wide range of household cleaning and home care products.

This is a hands-on role offering the opportunity to lead projects from concept through to commercial launch, working closely with production, quality, procurement, and commercial teams.

The Role

You will be responsible for developing innovative formulations, improving existing product performance, and supporting the transfer of products from laboratory scale into full manufacturing.

Product categories may include:

Surface and multi-purpose cleanersLaundry and fabric care productsDishwashing formulationsBathroom and toilet cleanersFloor care productsOther household and specialist cleaning solutions

Key responsibilities include:

Developing and optimising product formulationsAssessing and selecting suitable raw materials and ingredientsConducting laboratory testing, stability studies, and performance evaluationsInvestigating formulation and manufacturing challengesSupporting scale-up activities and production trialsMaintaining technical documentation and product specificationsEnsuring products meet relevant regulatory and quality requirementsMonitoring market trends, ingredient developments, and innovation opportunitiesWorking cross-functionally to deliver projects on time and within budget

About You

We're interested in speaking with formulation chemists who have experience within household care, detergents, FMCG, industrial cleaning products, or a related sector.

You will ideally have:

3+ years of proven formulation and product development experienceKnowledge of surfactant chemistry and cleaning systemsExperience in taking products from development through to manufactureUnderstanding of product stability, compatibility, and performance testingExperience supporting production and troubleshooting formulation issuesStrong project management and organisational skillsExcellent communication skills with the ability to work across multiple departments

What's on Offer

Opportunity to join a well-established manufacturing businessVaried technical role with genuine influence on product developmentCareer progression within a growing organisationCompetitive salary and benefits package

For a confidential discussion or further information, please apply today and speak to Rick @Smart4 Sciences

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Quality Audit Officer - Bedford

Are you a detail‑driven quality professional with a passion for compliance and client engagement? One of our leading pharmaceutical partners is seeking a Quality Audit Officer to join the Bedford team, where you'll play a pivotal role in hosting client audits and driving the self‑inspection programme across the business. This client‑facing role places you at the forefront of audit activities, ensuring compliance with ISO 9001, ISO 13485, and GDP regulations while building strong relationships with client quality teams.

Working alongside the Quality Integration Manager, you'll arrange and host audits, draft and submit audit responses, and act as the main point of contact for client queries. You'll also support regulatory inspections, lead self‑inspections, and contribute to continuous improvement initiatives that strengthen the company's Quality Management System.

Key Responsibilities

Arrange, host, and respond to client audits at Bedford and other UK sites as required

Act as subject matter expert or provide backroom support during regulatory inspections

Organise, perform, and report on self‑inspections across the UK

Oversee supplier qualification and maintain the Approved Supplier List

Conduct detailed root cause analysis of non‑conformances and implement corrective actions

Perform and facilitate risk assessments on GxP and quality processes

Identify training needs and update quality training materials based on audit findings

Review and improve SOPs, work instructions, and forms to ensure compliance and consistency

Build strong client relationships and communicate clearly with external quality teams

What We're Looking For

Minimum 3 years' experience in a quality department certified to ISO 9001 or ISO 13485

Strong working knowledge of GDP guidelines and Quality Management Systems

Experience in quality auditing and supplier qualification programmes

Skilled in Microsoft Office packages (Excel, Word, Visio, PowerPoint, Outlook)

Ability to work independently and in a team, under pressure and to strict deadlines

Confident communicator with excellent organisational and problem‑solving skills

Desirable:

QMS Lead Auditor qualification

Certified training within GxP

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NPD / Project Manager - Household - Worcestershire | Site-Based

A growing manufacturing business within the FMCG and consumer chemicals sector is looking to appoint an experienced NPD / Project Manager to support ongoing product innovation and development activity across its expanding product portfolio.

Working closely with the Technical Director, you'll play a key role in driving projects from concept through to commercial launch, ensuring products are delivered efficiently, compliantly, and to the highest standards. The role also offers the opportunity to lead and develop a small technical team while collaborating with departments across the wider business.

This position would suit someone who enjoys a varied and hands-on environment where no two projects are the same and where strong organisation, technical understanding, and stakeholder management are essential.

The Opportunity
* Manage the full lifecycle of new product development projects from brief through to launch
* Coordinate activity across technical, manufacturing, procurement, quality, packaging, and commercial teams
* Support formulation updates, product enhancements, and cost-saving initiatives
* Oversee manufacturing trials, pilot batches, and first production runs to ensure smooth scale-up activity
* Maintain compliance with relevant industry legislation and internal quality standards
* Ensure technical records, specifications, and supporting documentation are accurately maintained
* Identify opportunities for continuous improvement across products, processes, and operational practices
* Provide guidance and support to junior members of the development team

What We're Looking For
* Experience gained within FMCG, household products, cosmetics, detergents, chemicals, or a similar manufacturing environment
* Previous involvement in product development, technical projects, or formulation-led activities
* Strong ability to manage workloads, deadlines, and multiple stakeholders effectively
* Understanding of relevant regulations and compliance requirements including REACH, CLP, COSHH, and associated industry standards
* Confident communication skills with a proactive and solutions-focused approach
* Comfortable working within a fast-moving manufacturing setting where priorities can change quickly
* Knowledge of product trials, manufacturing processes, or commercialisation activities would be advantageous

Why Apply?
* Join a business continuing to invest in innovation and product development
* Work closely with senior leadership and contribute to key strategic projects
* Opportunity to make a visible impact within a collaborative and supportive team environment
* Genuine scope for involvement in continuous improvement and future product direction

Benefits
* Bupa EAP
* Death in Service cover from day one
* Digital health and wellbeing services
* Cycle to Work scheme
* Quarterly attendance bonus
* Internal incentive schemes

For more information or to apply, please send your CV to Rick Metcalfe @Smart4 Sciences.

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Automation & CSV Engineer (Permanent) - West Yorkshire

Pharmaceutical Manufacturing | High-Tech GMP Environment | Career Growth Opportunity

An exciting opportunity is available for an Automation & Computer System Validation (CSV) Engineer to join a highly regulated manufacturing environment within the pharmaceutical/life sciences sector.

This role is ideal for an engineer who enjoys working at the intersection of automation, validation, digital systems, and manufacturing operations. You'll play a key role in supporting critical production systems, driving continuous improvement initiatives, and ensuring compliance across computerized and automated processes.

Key Responsibilities

Support and maintain automation and control systems across manufacturing operationsTroubleshoot equipment and process-related automation issuesParticipate in computerized system validation (CSV) activities within a GMP-regulated environmentAssist with qualification, commissioning, and lifecycle management of automated systemsSupport continuous improvement and process optimization projectsCollaborate with engineering, production, quality, and external vendorsMaintain technical and validation documentation in line with regulatory expectationsContribute to data integrity and compliance initiativesProvide technical support and training to operational teams

Ideal Background

Degree qualified in Automation, Electrical, Electronics, Mechatronics, or related Engineering disciplineExperience working with PLC, HMI, SCADA, or industrial control systemsExposure to regulated industries such as pharmaceuticals, biotech, medical devices, or food manufacturing preferredUnderstanding of GMP and computerized system validation principlesStrong troubleshooting and problem-solving skillsAbility to work both independently and within cross-functional teamsExcellent communication and technical documentation abilities

Desirable Experience

PLC/SCADA programming or supportSystem integration projectsEquipment qualification or validation activitiesKnowledge of data integrity and regulatory compliance requirementsExperience supporting utilities, manufacturing systems, or process equipment

What's on Offer

Opportunity to work in a modern, highly automated manufacturing environmentExposure to cutting-edge pharmaceutical technologiesCareer progression within engineering and digital manufacturingCollaborative and technically focused cultureCompetitive salary and benefits packag

This is an excellent opportunity for an ambitious engineer looking to develop within a fast-paced and growing technical operations environment.

For a confidential discussion or to learn more, please contact Simon Fowler on

+44 (0)1925 239 725 or

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Quality Assurance Manager - FMCG Manufacturing
📍 Worcestershire

An established and growing manufacturing business is seeking an experienced Quality Assurance Manager to lead site quality and compliance activities within a fast-paced production environment.

This is a highly visible role with responsibility for maintaining and improving quality systems, audit readiness, product compliance, and operational standards across the site.

The Role

Key responsibilities will include:

Managing and developing the site Quality Management SystemLeading HACCP reviews and site risk assessmentsCoordinating internal audits and supporting external audits/customer visitsDriving GMP, hygiene, and continuous improvement standardsManaging investigations, non-conformances, CAPAs, and root cause analysisOverseeing SOP control and quality documentation processesSupporting supplier and packaging quality investigationsLeading and developing a quality team within a busy manufacturing operation

Candidate Profile

We are interested in speaking with candidates from a variety of regulated or high-volume manufacturing sectors, including:

Food manufacturingFMCGPharmaceuticalPersonal careCosmeticsOther high-care or highly regulated production environments

Direct sector experience is beneficial but not essential where candidates can demonstrate strong transferable quality and compliance expertise.

Key Requirements

Suitable applicants will ideally possess:

Proven experience within a QA or technical leadership roleStrong understanding of BRC standards and leading audit preparationExperience managing internal and external auditsHACCP qualification with practical implementation experienceKnowledge of QMS management and continuous improvement methodologiesStrong problem-solving and corrective action experiencePrevious people management and stakeholder engagement experienceA hands-on approach with the ability to work closely with operational teams

Additional Information

Experience working within a BRC-accredited manufacturing environment is highly desirable.HACCP Level 3 minimum preferred; Level 4 advantageous.The role combines both operational shop-floor presence and quality systems management responsibilities.Candidates should be comfortable leading teams, managing compliance activities, and supporting a strong quality culture across site.

This opportunity would suit an ambitious quality professional looking to make a significant impact within a dynamic manufacturing business. Please contact Rick @smart4 sciences for more info

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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

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