Regulatory Affairs Specialist, Amersfoort, Utrecht

About the Company A global leader in pharmaceutical manufacturing, committed to delivering high-quality healthcare products that improve patients' lives worldwide. The company operates within a highly regulated environment and is dedicated to maintaining the highest standards of quality, compliance, safety, and operational excellence. Role Description We are seeking a motivated and detail-oriented Pharmaceutical Manufacturing Associate to join a dynamic production team. In this role, you will be responsible for supporting manufacturing operations in a GMP-regulated environment, ensuring all production activities are carried out in accordance with approved procedures, quality standards, and safety requirements. Responsibilities - Execute manufacturing activities in accordance with Standard Operating Procedures (SOPs) and GMP regulations. - Perform manual production and operational tasks to support manufacturing processes. - Conduct in-process quality checks to ensure product quality and compliance. - Accurately complete batch records, logbooks, and production documentation. - Identify, report, and support the investigation of deviations and quality issues. - Assist with equipment preparation, setup, cleaning, and maintenance activities. - Support production changeovers and operational readiness activities. - Ensure the manufacturing area remains clean, organized, and audit-ready. - Follow all safety, quality, and compliance requirements at all times. - Collaborate with Production, Quality Assurance, and other cross-functional teams to achieve operational goals. - Participate in continuous improvement initiatives and team meetings. - Maintain a proactive approach to problem-solving and operational efficiency. Requirements - Minimum 2 years of experience operating manual and/or semi-automated production lines within a manufacturing environment. - Experience working within a GMP-regulated environment is highly preferred. - Good understanding of manufacturing processes, SOPs, and quality standards. - Fluent in English, both written and verbal. - Strong attention to detail and commitment to quality. - Ability to work effectively in a structured and process-driven environment. - Comfortable performing repetitive tasks with accuracy and consistency. - Strong teamwork and communication skills. - Willingness to work in a shift operation.  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 internationale farmaceutische organisatie die innovatieve geneesmiddelen ontwikkelt binnen een sterk gereguleerde GMP-productieomgeving. Functieomschrijving Als Maintenance Engineer ondersteun je de Business System Owner bij het beheer van farmaceutische watersystemen, waaronder WFI/WDI, BMS en EMS. Je zorgt voor de betrouwbaarheid van installaties, GMP-compliance en operationele gereedheid en draagt bij aan onderhoudsstrategieën, investeringsplannen en technische projecten. Belangrijkste verantwoordelijkheden Beheren van clean utility-assets om betrouwbaarheid, beschikbaarheid, kwaliteit en kostenefficiëntie te waarborgen Ondersteunen van langetermijnonderhoudsstrategieën en CAPEX-investeringsplannen Beoordelen en beheren van wijzigingen (MoC) tijdens ontwerp, commissioning en kwalificatie Beoordelen van technische gegevens en de impact van voorgestelde wijzigingen Ondersteunen van engineeringprojecten en zorgen voor een goede overdracht en operationele gereedheid Bewaken van naleving van GMP-, EHS- en interne assetmanagementvereisten Identificeren en implementeren van verbeteringen aan clean utility-systemen Samenwerken met de Business System Owner en de Maintenance- en Engineeringteams Vereisten Minimaal 2 jaar ervaring binnen een farmaceutische/GMP-omgeving Praktische ervaring met WFI/WDI-clean utility-systemen — must-have Ervaring met assetmanagement en onderhoud van farmaceutische utilities Kennis van BMS en besturingssystemen voor clean utilities Kunnen lezen en aanpassen van P&ID's Kennis van GMP, Management of Change, commissioning en kwalificatie Goede communicatieve vaardigheden in het Engels & Nederlands Ervaring met SAP PM of andere CMMS-systemen is een pré Ervaring met CAPEX-planning en investeringsprojecten is een voordeel

Company A leading pharmaceutical manufacturing facility committed to delivering life-changing medicines worldwide. The organization operates a modern and highly automated site, employing a diverse team dedicated to maintaining safety, quality, and efficiency across all operations. Job Description We are seeking a skilled and proactive Senior Utility Systems Technician to oversee and maintain critical utility systems that support manufacturing, warehousing, and office functions. The role combines technical expertise, leadership, and a focus on continuous improvement to ensure the reliable operation of essential infrastructure. Responsibilities - Coordinate and prioritize maintenance activities for utility systems and facility infrastructure. - Provide technical guidance, coaching, and support to technicians, contractors, and team members. - Assist in troubleshooting complex issues related to utilities and building systems. - Collaborate with facilities, engineering colleagues, vendors, and contractors to resolve technical challenges. - Drive initiatives to improve system reliability and operational efficiency. - Participate in an on-call rotation to support critical utility systems outside regular working hours. Requirements - Technical education at MBO+/HBO level or equivalent experience. - Experience in utilities, facilities maintenance, or industrial settings. - Strong troubleshooting skills and a hands-on approach. - Proven ability to coordinate maintenance projects and work effectively with teams. - Good communication skills in English. - Willingness to participate in an on-call schedule. - Experience in a GMP environment and familiarity with SAP PM or other CMMS platforms is a plus. 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 globally operating organization in the life sciences sector, focused on delivering high-quality medicines for patients worldwide. The site in the Netherlands plays a key role in labelling, packaging, storage, and distribution for both commercial and clinical supply chains, working in a fast-paced, international environment with high quality and compliance standards. Job Description For our client in Breda, we are looking for a Clinical Supply Chain Quality Assurance Specialist to provide QA oversight across the clinical supply chain and support production-related quality activities. The role ensures investigational medicinal products are handled in full compliance with GMP/GDP requirements, supporting smooth release, distribution, and packaging/labelling operations for clinical trials. Responsibilities - Provide quality guidance and oversight for investigational medicinal products to ensure GMP/GDP compliance - Review batch documentation to support batch certification activities - Review and approve clinical label artwork and support packaging/labelling quality checks - Assess and document temperature excursions during transport and at clinical sites/depots - Support investigation and resolution of quality/compliance issues related to manufacturing, packaging, and distribution - Review and approve minor deviations in line with internal procedures and regulatory expectations - Draft, update, and maintain operational SOPs and work instructions - Review SOPs to ensure alignment with corporate standards, site procedures, and regulatory requirements - Prepare and contribute to monthly quality metrics and reporting - Work cross-functionally with stakeholders across supply chain, warehouse/distribution, production, - quality, clinical operations, and regulatory teams - Perform QA-on-the-floor activities such as pack checks, batch record review, and compliance checks - ---during manufacturing activities Requirements - Master’s degree (preferably Life Sciences or a related field) - Several years of experience in Quality Assurance and/or manufacturing within pharma, biotech, or medical devices - Hands-on experience with documentation review (e.g., batch records) and deviation/investigation support - Solid knowledge of GMP and GDP (GCP is a plus) - Strong attention to detail, structured way of working, and a compliance-focused mindset - Good communication skills and ability to collaborate with multiple stakeholders - Fluent in English Other Information The role is based on-site in Breda and offers the opportunity to work in an international environment supporting clinical trial supply activities end-to-end. If you are interested and want to apply, please submit your application via the apply button below and contact me.

Company A global manufacturing organization operating within a GMP-regulated environment, focused on delivering quality products that improve patients' lives. The company values innovation, teamwork, operational efficiency, and a strong culture of compliance and continuous improvement. Role Description As you are responsible for operating high-tech manufacturing equipment in a GMP-regulated environment, ensuring production runs smoothly, efficiently, and in full compliance with strict quality standards. As a Manufacturing Process Technician, you play a critical role in supporting the timely delivery of high-quality medicines, contributing directly to the organization’s commitment to patients and operational excellence. Responsibilities - Operate and monitor automated production and packaging equipment in line with GMP and SOP requirements. - Perform troubleshooting and root cause analysis (RCA) to resolve equipment and process issues. - Optimize machine settings and process parameters to improve efficiency and performance. - Maintain accurate GMP documentation, batch records, and production logs. - Record and verify production data using SAP, MES, or ERP systems. - Participate in cross-functional problem-solving and triage meetings with QA, Maintenance, and Production teams. - Carry out equipment setup, changeovers, line clearance, and shutdown activities. - Execute routine cleaning and basic maintenance activities. - Support Lean Manufacturing and Continuous Improvement initiatives. - Ensure effective shift handovers and maintain a safe, compliant, and organized workplace. Requirements - 3+ years of experience in automated production, manufacturing, assembly, or packaging environments. - Experience within Pharmaceutical, Biotechnology, Food, FMCG, or other regulated industries. - Knowledge of GMP regulations, SOPs, and quality standards. - Experience with SAP, MES, or other manufacturing systems. - Strong troubleshooting skills using RCA, 5 Why, Fishbone, Kaizen, TPM, or SMED methodologies. - Technical understanding of automation systems, mechatronics, pneumatics, sensors, and machine components. - Experience with Lean Manufacturing and Continuous Improvement programs. - Technical qualification such as MBO, VAPRO B, Engineering, Mechatronics, or equivalent. - Good communication skills and ability to work effectively with cross-functional teams. - Fluent in English and willing to work in a shift-based manufacturing environment. 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 an international manufacturing company operating in a highly regulated production environment. The organisation uses advanced automated manufacturing and packaging technologies to deliver high-quality products while maintaining strong standards for safety, compliance, and operational excellence. The site values teamwork, continuous improvement, technical expertise, and innovation. Job Description We are looking for a Manufacturing Operator to join a dynamic production team. In this role, you will help keep semi-automated production and packaging lines running safely, efficiently, and according to GMP requirements. You will monitor equipment, handle basic technical issues, complete production activities, and support the team in keeping production running smoothly. Roles & Responsibilities - Run and monitor semi-automated production and packaging lines in a GMP environment. - Set up and start production equipment according to SOPs and production instructions. - Check and adjust machines and process settings when needed. - Carry out cleaning, product changeovers, line clearance, and basic equipment checks. - Identify and troubleshoot machine or process issues to reduce production downtime. - Make basic machine adjustments to keep the production process running smoothly. - Record and verify production information in SAP, MES, and other manufacturing systems. - Complete batch records, equipment logs, and other production documentation accurately. - Check product quality during production and report deviations or abnormalities. - Perform first-line checks and basic maintenance when required. - Follow GMP, SOPs, safety rules, and site procedures at all times. - Coordinate with Production, Maintenance, and Quality teams to resolve technical or production issues. - Support root cause investigations using methods such as 5 Why and RCA. - Contribute to continuous improvement initiatives using Lean and Kaizen principles. - Communicate clearly during shift handovers and share relevant production information with colleagues. Requirements - Technical education at MBO level or an equivalent qualification such as VAPRO B. - Experience in automated production, assembly, packaging, or process manufacturing. - Good technical understanding and the ability to identify and solve production issues. - Familiarity with RCA, 5 Why, Lean, or Kaizen is an advantage. - Experience in GMP or another regulated manufacturing environment is highly desirable. - Knowledge of SAP, MES, or similar production systems. - Good communication skills in English. - Willingness to work rotating 3-shift and 5-shift schedules. - Available for a temporary full-time contract (1 year). Why Apply? This role is a great opportunity for someone who enjoys working with modern manufacturing technology and solving technical production challenges. If you're ready for your next challenge in automated manufacturing, we'd love to hear from you. Apply today by clicking the application button below or contact me directly for more information.

About the Company An international biopharmaceutical organization with a modern manufacturing site in Breda, supplying medicines to patients worldwide. Role Description As Lead Technician Utilities, you will coordinate maintenance activities and support the reliable operation of critical utility systems across manufacturing, warehousing and office facilities. You will combine hands-on technical expertise with team coordination and coaching, while driving equipment reliability, safety and continuous improvement. Key Responsibilities Coordinate and prioritize maintenance across utility systems and facility infrastructure Provide technical guidance and coaching to technicians and contractors Troubleshoot complex utility and facility issues Coordinate with Engineering, Facilities, Operations and external service providers Drive equipment reliability and continuous improvement initiatives Support systems including HVAC, refrigeration, compressed air, chilled water, boilers and building automation Participate in the on-call rotation for critical utility systems Requirements Experience in utilities, facilities, maintenance or industrial installations Strong troubleshooting skills and a hands-on approach Experience coordinating maintenance, contractors, projects or technical teams Strong communication and coaching skills Good command of English Willingness to participate in an on-call rotation GMP experience and knowledge of SAP PM or another CMMS are a plus

Company A leading organization committed to advancing supply chain efficiency and digital innovation within the pharmaceutical industry. The company emphasizes operational excellence, collaboration, and continuous improvement to support its global health initiatives. Job Description We are seeking a knowledgeable and proactive Supply Chain Digital Transformation Specialist to join our team. In this role, you will support global supply chain digital projects, optimise processes, and act as a key liaison for systems and operational improvements within the OTC and PTS areas. Responsibilities -Provide daily operational support for ERP systems, ensuring smooth execution of OTC and PTS processes, including access management, troubleshooting, and training -Assist in the implementation of global digital supply chain initiatives, such as ERP and EDI systems -Maintain and update master data in ERP systems for sales views and product launches -Track and report on the progress of global supply chain projects and initiatives -Lead or contribute to process improvement projects, gathering business -requirements, conducting user acceptance tests, and documenting changes -Manage minor system enhancements and updates to departmental SOPs, work instructions, and training materials -Act as a subject matter expert for PTS and OTC processes, representing the -global supply chain in cross-functional teams including compliance and quality groups -Support the development of business cases and project charters for ERP system improvements -Facilitate continuous process improvements and participate in multiple initiatives to optimise supply chain performance Requirements -Bachelor’s degree in logistics, economics, information technology or related fields -Minimum of 3 years' experience in international supply chain management, preferably in the pharmaceutical industry -Proficiency in MS Office and ERP systems, preferably SAP (especially OTC and PTS modules) -Strong understanding of end-to-end supply chain processes, digital supply chain tools, and EDI communication methods -Experience managing cross-cultural teams and working across different geographies -Proven project management skills and business ownership experience -Excellent analytical, communication, and presentation skills -Fluent in English, both written and spoken Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me.  

Company A leading organization in the fast-moving consumer goods sector, specializing in food and dairy products. The company values customer focus, operational excellence, and international collaboration, fostering a dynamic environment where teams work together to deliver outstanding service globally. Job Description The Customer Operations Coordinator will play a vital role in managing the end-to-end order-to-cash process for export customers across the Americas and Europe. This position requires a proactive and customer-oriented professional to ensure smooth operations, coordinate with internal departments, and deliver exceptional service in an international setting. Responsibilities - Act as the primary contact for customers regarding orders and deliveries. - Manage the full order process and related documentation within SAP. - Monitor order execution and proactively resolve any issues by collaborating with internal teams. - Maintain daily communication with customers and internal stakeholders, including Supply Planning, Demand Planning, Logistics, and Sales. - Handle order inquiries, resolve complaints, and support continuous improvement initiatives. - Keep logistical master data and customer-specific requirements up to date. - Assist in forecasting activities through stock and sales reporting where relevant. - Participate in project-based work and operational improvement initiatives to enhance efficiency. Requirements - HBO level education and working experience. - Prior experience in Customer Service, Customer Operations, Supply Chain, or Logistics. - Experience using SAP or similar ERP systems. - Strong skills in Microsoft Excel and Office. - Fluency in Dutch and English; Spanish language skills are a plus. - Excellent communication and stakeholder management abilities. - Accurate, proactive, and customer-focused with the ability to work independently. - Interest in process improvement and ongoing learning. - Experience in FMCG, Food, or Dairy industries is highly advantageous. Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me. The role involves significant contact with international customers and internal teams, requiring flexibility, ownership, and the ability to manage multiple priorities effectively. 

The Company A global pharmaceutical manufacturing organization focused on producing high quality medicines and healthcare products. The company operates in highly regulated production environments with a strong emphasis on safety, operational excellence, quality compliance, and continuous employee development About the Role We are seeking motivated Production Operators to support manufacturing activities in a regulated pharmaceutical production environment. This position is ideal for candidates looking to build a strong foundation in GMP manufacturing while gaining hands on experience with production processes, equipment operation, and quality systems. Responsibilities - Execute production activities according to approved procedures, GMP requirements, and safety standards - Prepare production materials, equipment, and work areas for operational activities - Operate production equipment following training and approved instructions - Complete accurate and timely documentation of all assigned activities - Follow GMP guidelines and quality requirements at all times - Identify deviations, abnormalities, and safety concerns and escalate appropriately - Support smooth shift handovers and maintain effective communication within the team - Participate in training programs and on the job learning activities - Contribute to maintaining a safe, clean, and compliant production environment - Collaborate with operators and production colleagues to ensure operational continuity Requirements - MBO level education, preferably in a technical, manufacturing, engineering, pharmaceutical, biotechnology, or life sciences discipline - Fluent Dutch and English language skills, both written and verbal - Ability to work in a structured and regulated manufacturing environment - Strong attention to detail and commitment to quality - Understanding of GMP principles is advantageous - Willingness to work in rotating shift patterns - Strong team player with good communication skills - Reliable, accurate, and safety conscious work approach - Ability to learn new processes and technologies quickly - Flexible and adaptable mindset - Comfortable following standard operating procedures - Eligible to complete PESV screening Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me.