Quality Investigation Specialist, Leiden, Zuid-Holland

About the Company An international life sciences organization operating in a regulated manufacturing environment, focused on delivering high-quality pharmaceutical products through robust quality systems and continuous improvement. Role Description As Quality Engineer, you will lead quality investigations and manage deviations, non-conformances, CAPAs and change controls within manufacturing operations. You will work closely with Operations, Engineering, MSAT and QA to identify root causes, maintain GMP compliance and drive effective corrective actions across upstream and downstream processing. Key Responsibilities Lead deviation and non-conformance investigations from initiation to closure Manage CAPAs and change controls, ensuring timely and compliant completion Perform root cause analysis, including Fishbone Analysis Review and maintain quality records, procedures and technical documentation Coordinate with Operations, Engineering, MSAT and QA Identify risks and implement corrective actions and quality improvements Support GMP compliance through production floor observations and GEMBA walks Escalate quality risks and communicate investigation findings to stakeholders Requirements Experience with QMS, deviations, non-conformances, CAPAs and change control Understanding of manufacturing operations, ideally USP and/or DSP Strong technical writing and documentation skills Experience with root cause analysis and investigation management Experience with COMET, TrackWise or Veeva is an advantage Pharmaceutical or biotechnology manufacturing experience preferred; food industry experience may also be considered Strong analytical, organizational and stakeholder management skills Available to work 2 days per week onsite, with additional onsite presence during onboarding

The Company A large international organization operating across manufacturing and consumer focused markets, with complex factory operations and cross functional business transformation programs. The organization places strong emphasis on financial control, investment planning, operational performance, compliance, and effective collaboration between its factories and shared services. About the Role The Budgeting & Forecasting Lead will lead financial planning and analysis activities supporting factory operations and complex business transformation initiatives. The position will manage forecasting, budgeting, financial modelling, investment evaluation, risk analysis, and management reporting. A major focus is providing senior stakeholders with accurate financial insights while ensuring factories maintain synchronized reporting and projects remain aligned with budgets, savings targets, and delivery schedules. Responsibilities - Lead forecasting, budgeting, financial planning, and financial modelling activities - Monitor financial performance against budgets and business case targets - Perform variance analysis and recommend corrective actions - Provide accurate financial information and insights to senior management - Evaluate capital investments across multiple factories - Perform sensitivity analysis and identify financial risks and mitigation measures - Develop financial reports covering transformation activities, factory performance, and project progress - Coordinate financial reporting between factories - Ensure accurate and synchronized reporting within Magnitude - Support compliance with applicable accounting standards and regulations - Provide financial information required by shared services to support NRC eligibility requirements - Partner with operations, supply chain, IT, HR, and shared services teams - Support project managers with budget control and delivery of planned savings - Communicate financial performance, opportunities, and risks to senior stakeholders - Build strong stakeholder relationships to support successful project execution Requirements - Strong financial planning and analysis capability - Forecasting and budgeting expertise - Financial modelling experience - Variance analysis skills - Experience evaluating capital investments - Financial risk and sensitivity analysis capability - Strong management reporting skills - Understanding of accounting standards and financial compliance - Ability to coordinate financial reporting across multiple factories or business units - Experience supporting complex projects or transformation programs - Strong stakeholder management and communication skills - Ability to work effectively with cross functional teams - Ability to translate financial information into actionable recommendations for senior management - Experience supporting project budgets, savings targets, and financial performance Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me.

Over het bedrijf Onze opdrachtgever is een internationaal productiebedrijf met een sterke focus op efficiënte productie, supply chain performance en klanttevredenheid. Je komt terecht in een centraal planningsteam dat meerdere productielocaties ondersteunt. Functieomschrijving Als Supply Planner ben je verantwoordelijk voor de wekelijkse supply planning van 3–5 productielocaties. Je vertaalt de vraag naar realistische productieplannen en bewaakt daarbij de balans tussen klanttevredenheid, productiecapaciteit en efficiënte voorraadniveaus. Belangrijkste verantwoordelijkheden Verantwoordelijk voor de wekelijkse supply planning van 3–5 productielocaties. Vertalen van de vraag naar productieplannen en wekelijkse planningsbuckets. Evalueren van gerealiseerde productie en aanpassen van toekomstige plannen. Plannen op korte en middellange termijn, van komende weken tot één jaar vooruit. Samenwerken met productielocaties en planningsaannames kritisch beoordelen. Balanceren van klanttevredenheid en efficiënte productie. Signaleren van planningsrisico's, capaciteitsproblemen en supply constraints. Bijdragen aan continue verbetering binnen de centrale planning. Vereisten HBO-opleiding in Supply Chain, Logistiek, Bedrijfskunde of vergelijkbaar. 1–5 jaar relevante ervaring binnen supply chain of planning. Sterke analytische vaardigheden en goede kennis van Excel. Ervaring met Slim4/SlimStock is een pré. Ervaring met supply-, productie- of demand planning. Ervaring met zowel korte als middellange planning. Kritische en analytische instelling en de overtuiging om stakeholders uit te dagen. Goede communicatieve en stakeholdermanagementvaardigheden. Goede beheersing van Nederlands en Engels.

The company Our client is a leading international organisation with a strong focus on operational excellence, financial performance, and continuous improvement across its business operations.   Role Description As an Operations Business Controller, you will play a key role in supporting financial planning, performance management, and strategic decision-making across operational and factory environments. You will provide financial insights, monitor business performance, evaluate investments, and work closely with cross-functional stakeholders to drive efficiency, cost control, and sustainable business results.   Responsibilities - Lead financial planning activities, including budgeting, forecasting, financial modelling, and performance tracking. - Monitor financial performance against budgets and business case targets, providing variance analysis and recommending corrective actions. - Evaluate capital investments across factories, assessing financial viability, risks, and potential returns. - Analyse financial risks and sensitivities to support operational and strategic decision-making. - Prepare accurate financial reports, management updates, and performance insights for senior stakeholders. - Coordinate factory reporting activities and ensure consistent, reliable financial information through relevant reporting systems. - Work closely with Operations, Supply Chain, IT, HR, and shared service teams to support business initiatives and cross-functional projects. - Monitor budget delivery, cost efficiency, and savings initiatives, ensuring alignment with business objectives. - Support process improvements and change management initiatives that strengthen financial control and operational performance. - Ensure compliance with applicable accounting standards, internal financial controls, and relevant company policies. Requirement - Bachelor’s or Master’s degree in Finance, Business Economics, Accounting, or a related field. - Proven experience in business controlling, financial planning and analysis (FP&A), or operational finance. - Strong knowledge of budgeting, forecasting, financial modelling, and variance analysis. - Experience supporting factory operations, manufacturing, or supply chain environments is an advantage. - Ability to evaluate capital investments, analyse financial risks, and translate financial data into actionable business insights. - Experience with financial reporting systems and tools; familiarity with Magnitude or similar reporting platforms is an advantage. - Strong analytical, problem-solving, and stakeholder-management skills. - Ability to collaborate effectively with senior management and cross-functional teams. - Proactive, structured, and comfortable managing multiple priorities in a dynamic environment. - Fluency in English; additional language skills are an advantage. Other information If you are interested and want to apply, please submit your application via the apply button below and contact me.

Over het bedrijf Een toonaangevende industriële organisatie die werkt aan de verdere ontwikkeling en implementatie van haar HSE-strategie (Health, Safety & Environment). Functieomschrijving Als Projectmanager HSE leid je complexe, multidisciplinaire projecten van strategie tot implementatie en borging. Je vertaalt strategische doelstellingen, risico's en wettelijke verplichtingen naar concrete projectplannen en werkt samen met HSE-specialisten, werkeenheden, management en externe partijen om duurzame resultaten te realiseren. Belangrijkste verantwoordelijkheden Leiden van complexe HSE-projecten van start tot implementatie en borging Vertalen van strategische doelen en wettelijke verplichtingen naar projectplannen en businesscases Bewaken van scope, planning, budget, kwaliteit, risico's en resultaten Organiseren van projectgovernance en besluitvorming met management en stuurgroepen Aansturen van multidisciplinaire projectteams en verduidelijken van verantwoordelijkheden Verbinden van HSE-specialisten, werkeenheden, stafafdelingen en externe partijen Rapporteren over voortgang, risico's, afwijkingen en benodigde besluiten Zorgen voor een goede overdracht en duurzame implementatie binnen de organisatie Vereisten Ruime ervaring met project- of programmamanagement in een complexe technische of industriële omgeving Ervaring met transformatie, verandermanagement en risicobeheersing Sterk in strategische projectsturing, stakeholdermanagement en bestuurlijke besluitvorming Overtuigende communicatieve vaardigheden in Nederlands en Engels VCA-VOL-certificaat Een relevante project- of programmamanagementcertificering is een pré

Company Our client is a large, regulated production organisation with a strong focus on quality, continuous improvement, and collaboration across operations, technology, and R&D. The site environment is dynamic, with ongoing system and process changes that require structured, pragmatic quality support.   Job Description We are looking for a Quality Systems Specialist to strengthen the Quality Assurance team during an important system transition. The Senior Quality Systems Specialist will work independently to optimise quality systems and ways of working, bring structure to document management, and help drive improvement projects across multiple departments in a fast-paced production environment.   Responsibilities - Identify opportunities to improve QA processes and translate them into practical, structured solutions. - Initiate, coordinate, and implement process improvements within the QA organisation. - Optimise quality systems and document management processes, including the - Document Management System (DMS). - Support the QA team during a major system transition, ensuring continuity and clarity in quality-related workflows. - Coordinate QA-related activities across departments and align priorities with key stakeholders. - Collaborate closely with Production, Technology, R&D, and supporting functions to ensure quality topics are handled effectively. - Advise stakeholders on quality-related questions and improvement initiatives. - Identify risks and improvement opportunities within existing processes and convert these into concrete actions.   Requirements - Completed HBO or WO education in a relevant field. - Strong, proven experience in Quality Assurance / Quality Systems within a regulated production environment (food industry experience is a strong advantage). -Experience with quality systems, document management, and process optimisation. - Comfortable working independently and setting priorities in a changing environment. - Strong communication skills and the ability to bring people along in change. - Experience with SAP and tools such as SharePoint / Microsoft 365 and document management systems. - Fluent in Dutch (Frisian is a plus). - Temporary Full-Time (7 Months) Contract   Other Information The role is based in Leeuwarden, with the expectation to be on-site. If you are interested and want to apply, please submit your application via the apply button below and contact me.

Over het bedrijf Een internationale farmaceutische organisatie die vanuit de locatie in Haarlem duizenden geneesmiddelen- en vaccinverpakkingen naar meer dan 140 landen distribueert. De locatie werkt binnen een sterk gereguleerde GMP-omgeving met nauwe samenwerking tussen Productie, Quality Control en Quality Assurance. Functieomschrijving Als Quality Release Officer ondersteun je het vrijgeven van farmaceutische en vaccinbatches en zorg je ervoor dat aan alle kwaliteitseisen wordt voldaan tijdens productie en verpakking. Je werkt nauw samen met Quality Assurance, Quality Control, productie en Qualified Persons en ondersteunt onder andere deviatieonderzoeken, CAPA's, change controls en kwaliteitsprojecten. Belangrijkste verantwoordelijkheden Beoordelen en ondersteunen van deviatie-, CAPA- en marktklachtonderzoeken Ondersteunen van GMP-kwaliteitssystemen en kwaliteitsverbeteringen Vertegenwoordigen van Quality binnen projecten en nieuwe productintroducties Ondersteunen van afdelingen bij GMP-vereisten en wijzigingen in richtlijnen Beoordelen en autoriseren van GMP-documentatie, waaronder SOP's, kwalificatie/validatie en change controls Ondersteunen van batch release-activiteiten samen met Qualified Persons Beoordelen van kwalificatiedocumentatie zoals URS'en, protocollen en rapporten Verifiëren van kwalificatiedocumenten opgesteld door externe partijen Samenwerken met interne klanten en verschillende afdelingen Vereisten Ervaring met GMP Ervaring met farmaceutische verpakking en/of Quality Control is een pré Ervaring met kwalificatiedocumentatie en geautomatiseerde/laboratoriumsystemen SAP-ervaring is een pré Nauwkeurig, zelfstandig en resultaatgericht Sterke samenwerkings- en communicatieve vaardigheden Goede beheersing van Nederlands en Engels

Company Our client is a leading global organization focused on innovation, technology, and sustainable growth. The organization is currently modernizing its SAP landscape and is looking for an experienced professional to lead key transformation projects. Role Description We are looking for an experienced SAP Project Manager to lead complex SAP upgrade, migration, and modernization projects. You will be responsible for managing the overall project, coordinating technical teams and external partners, and ensuring successful delivery within the agreed timeline, scope, and quality standards. Responsibilities - Plan and manage SAP technical projects, including S/4HANA upgrades and migrations. - Coordinate technical activities across SAP Basis, infrastructure, security, integrations, data migration, and testing teams. -Manage dependencies between different technical teams and project stakeholders. - Ensure project deliverables meet business requirements and technical standards. - Identify and manage project risks, issues, and dependencies. - Lead project governance, reporting, and progress tracking. - Work closely with internal teams, SAP experts, business stakeholders, and external implementation partners. - Communicate project progress, risks, and technical topics clearly to stakeholders. - Contribute to the continuous improvement and modernisation of the SAP landscape. Requirements - Proven experience managing SAP technical projects, preferably within an S/4HANA environment. - Strong experience with SAP upgrades, migrations, or technical - transformation projects. - Good understanding of SAP technical areas such as Basis, infrastructure, security, integrations, data migration, and testing. - Strong stakeholder and project management skills in complex, international environments. - Experience managing cross-functional teams, dependencies, risks, and project issues. - Excellent communication, organizational, and problem-solving skills. - Fluent in English, both written and spoken. - A strong technical background combined with solid project management experience. Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me.

The Company A leading global biotechnology organization with a strong focus on innovative manufacturing, advanced automation, quality, and operational excellence. The organization operates in a highly regulated GMP environment and invests in reliable, secure, and sustainable manufacturing technologies. Role Description As a Senior Automation Engineer, you are responsible for the automation aspects of new and upgraded manufacturing equipment across Device Assembly, Inspection, Labeling, and Packaging. You will oversee automation throughout the equipment lifecycle, from design and installation through commissioning, qualification, and operational support, while ensuring reliability, compliance, security, and continuous improvement. Responsibilities - Lead and manage automation activities according to project timelines and requirements. -Support New Product Introduction (NPI) activities and equipment implementation. - Author and review automation design documents, including URS, FDS, HDS, and SDS. - Support FAT, commissioning, testing, and qualification activities at vendors and on-site. - Implement automation hardware, software, and security standards. - Ensure equipment complies with required cybersecurity and monitoring standards. - Participate in Data Integrity Assessments and Automation Preventive Maintenance activities. - Develop backup/restore procedures, work instructions, parameter lists, and audit trail review procedures. - Support PI data historian connections and equipment data integration. - Advise on automation spare parts and develop asset spare-parts lists. - Provide automation training to Maintenance, Engineering, and relevant Operations teams. - Provide on-floor hypercare and troubleshooting support when required. - Monitor project progress and provide updates to Project Management. - Maintain and update documentation required for long-term operational support. Requirements - Bachelor’s or Master’s degree in Automation Engineering, Industrial Information Systems, or a related field. - At least 5 years of automation and process control experience in pharmaceutical or biotechnology manufacturing. - Proven experience with labeling and packaging equipment. - Knowledge of PLC, HMI, SCADA, Industrial PCs, and vision systems such as Cognex. - Strong understanding of GMP and regulated manufacturing environments. - Excellent communication, project management, and problem-solving skills. - Fluent in English and flexible to work outside standard office hours when required. Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me.

Company Our client is a well-established organisation within the process industry, operating a modern production environment with a strong focus on quality, compliance, and continuous improvement. The site has a professional logistics and planning function that supports day-to-day operations while also preparing for upcoming system and process changes. Job Description We are looking for a SAP Planning & Logistics Key User to strengthen the planning and logistics support function at the client’s site in Lochem. In this role, the SAP Planning & Logistics Key User combines strong planning know-how with deep ERP system expertise and acts as a go-to person for complex questions and issues. The focus is on supporting colleagues, improving processes, and ensuring stable operations during a period of high workload and upcoming changes. Responsibilities - Act as key user for the ERP environment, with a strong focus on SAP and warehouse/manufacturing planning processes. - Provide hands-on support to planning and logistics colleagues on complex system and process-related questions. - Troubleshoot issues, analyse root causes, and help implement sustainable improvements. - Support the planning and logistics function with operational topics and challenges as needed. - Serve as back-up for the Planning & Logistics Manager when required. - Step in as back-up for production scheduling activities when needed. - Contribute to preparing, testing, and documenting processes and work instructions in collaboration with the team and site stakeholders. - Communicate clearly with different stakeholders across the organisation and support a structured way of working. Requirements - HBO/WO working and thinking level (e.g., Logistics, (Technical) Business Administration, Supply Chain or similar). - Strong and proven SAP experience at key-user / expert level (able to go beyond executing transactions and understand how processes and transactions work). - Experience with warehouse and manufacturing planning processes; experience with SAP Extended Warehouse Management and planning tools is a strong advantage. - Analytical mindset and able to solve operational/logistics issues in a pragmatic way. - Flexible, stress-resistant, and a team player with strong communication skills. - Comfortable working on-site in Lochem and supporting a production environment. - Good command of both Dutch and English. - Temporary Full-Time Contract (8 Months) Other Information The role is based on-site in Lochem and involves close collaboration with planning, logistics, and site stakeholders. The selection process consists of one interview (online or on-site, depending on availability and preference). If you are interested and want to apply, please submit your application via the apply button below and contact me.