QA Associate (Shifts), Breda, Noord-Brabant

Company A leading global biotechnology organization dedicated to discovering, developing, and delivering innovative medicines for patients with serious illnesses. Driven by science and powered by advanced technology, the organization focuses on areas such as oncology, cardiovascular disease, inflammation, and rare diseases. Its mission is centered on improving lives by turning cutting-edge science into meaningful therapies that address unmet medical needs.   Job Description We are seeking a Mechanical System Owner Engineer to join our client’s team for an initial 6-month assignment (extension subject to performance and project needs). This is a fully onsite role focused on utility systems, maintenance support, and system lifecycle management within a regulated environment.   Responsibilities Act as System Owner for utility systems including Chiller (mandatory), HVAC, and Compressed Air (nice to have) Support maintenance activities and troubleshoot technical issues Lead maintenance improvements and Root Cause Analysis (RCA) Manage system lifecycle activities and recurring issues Collaborate with engineering teams and key stakeholders on projects and upgrades Requirements Bachelor’s or Master’s degree in Engineering (Mechanical preferred) Experience in GMP-regulated environments (pharma, biotech, or food industry preferred) Mandatory experience with Chiller systems Knowledge of HVAC and utility/building management systems Strong analytical, documentation, and stakeholder management skills Fluent in English and Dutch Availability for 24/7 on-call duty rotation (1–2 times per month) Other information Apply to our vacancy for more information. Looking forward to getting in touch!

The Company A leading organization in the biotechnology and advanced cell therapy sector focused on developing and manufacturing innovative treatments. The company operates in a highly regulated GMP environment with a strong emphasis on quality, patient safety, process excellence, and continuous improvement. Role Description This position supports the manufacturing of clinical and commercial cell therapy products within a GMP regulated environment. Successful candidates will be assigned to either the Production Team or Production Support Team after completing initial training requirements. The role requires hands on manufacturing activities, strict adherence to SOPs and GMP standards, and close collaboration with multiple operational and quality functions. Responsibilities - Perform apheresis accession and transfer to manufacturing areas - Complete batch records according to SOPs and GMP requirements - Support batch documentation review for product release activities - Supply manufacturing suites with required materials and components - Transfer batch records and documentation into cleanroom environments - Conduct final product visual inspections - Perform cryopreservation of excess cells and final product - Submit manufacturing samples to Quality Control - Manufacture clinical and commercial products in Grade A and Grade B cleanroom environments - Complete manufacturing batch records accurately and compliantly - Draft and revise batch records, SOPs, and work instructions - Support deviation investigations and corrective actions - Participate in change management implementation - Troubleshoot processing and equipment related issues - Collaborate with Production Support, Product Sciences, Materials Management, Quality Assurance, and Quality Control teams Requirements - MLO, MBO, or HBO qualification with a Life Sciences background - Experience working within a pharmaceutical, biotechnology, or related manufacturing environment - Proven knowledge of biotechnology or pharmaceutical manufacturing processes - Strong understanding of cGMP regulations and compliance requirements - Experience working within controlled cleanroom environments - Ability to work aseptically and follow strict gowning procedures - Strong troubleshooting and problem solving abilities 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 pharmaceutical manufacturing sector, committed to producing high-quality, safe medicinal products in a regulated environment. They prioritize continuous improvement, technological innovation, and a collaborative team culture to serve patients effectively. Job Description We are seeking a proactive and detail-oriented Quality Assurance Specialist to join the Plant QA team. This role involves providing essential quality oversight during packaging and labeling operations, supporting compliance initiatives, and ensuring documentation accuracy to meet GMP standards. Responsibilities - Conduct final quality checks on labeling and packaging processes before product release. - Review batch records to verify data accuracy, completeness, and compliance with procedures. - Handle quality issues by investigating deviations, documenting findings, and following up on corrective actions. - Collaborate closely with Production, Maintenance, and QA colleagues, providing guidance and escalation when necessary to halt production if quality concerns arise. - Maintain clear deviation documentation and support corrective and preventive actions. - Participate in ongoing GMP compliance activities, including GMP training, incident investigations, and quality improvement projects. - Review and approve operational SOPs and work instructions as needed. - Prepare and analyze weekly and monthly QA metrics and maintain departmental performance boards. - Act as a key point of contact for production-related quality queries and support cross-departmental cooperation. Requirements - MBO or BSc degree in Pharmaceutical, Life Sciences, or a related field, or equivalent experience. - Approximately 3 years of QA or manufacturing experience within the pharmaceutical or medical device sectors, with a focus on batch record review and investigations. - Strong knowledge of GMP, GDP, and/or GCP regulations, and experience applying them in routine activities. - Excellent attention to detail and technical knowledge in manufacturing and quality processes. - Fluent in English, with good communication and collaboration skills. - Resilience under pressure and assertiveness to address quality concerns confidently. Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me. This role involves working on a 3-shift schedule: early, late, and night shifts, with a fixed schedule for each week. 

Het Bedrijf Onze opdrachtgever is een toonaangevende internationale zuivelcoöperatie met meer dan 150 jaar ervaring. De organisatie richt zich op de productie van hoogwaardige zuivelproducten en voedingsingrediënten en zet sterk in op innovatie, duurzaamheid en operationele excellentie binnen een moderne, geautomatiseerde en hygiënische productieomgeving. Functieomschrijving Als Commercial Operations Specialist ben je verantwoordelijk voor het optimaliseren en automatiseren van commerciële processen op het gebied van pricing, masterdata en sales operations. Je werkt nauw samen met verschillende teams en maakt gebruik van SAP, Power BI, Power Query, Power Automate en andere Microsoft-tools om processen te verbeteren, de datakwaliteit te verhogen en continue verbeteringen te realiseren. Verantwoordelijkheden Analyseren, optimaliseren en automatiseren van commerciële processen binnen Pricing, Masterdata en Sales Operations. Ontwikkelen en implementeren van slimme automatiseringsoplossingen met SAP, Power BI, Power Query, Power Automate en andere Microsoft-tools. Verbeteren van de kwaliteit en betrouwbaarheid van prijsgegevens, masterdata en commerciële processen. Signaleren van knelpunten, uitvoeren van procesanalyses en realiseren van duurzame procesverbeteringen. Samenwerken met verschillende interne stakeholders om efficiëntere werkwijzen en datagedreven oplossingen te ontwikkelen. Documenteren en standaardiseren van processen om de continuïteit en kennisborging binnen de organisatie te versterken. Functie-eisen Afgeronde hbo- of wo-opleiding, bij voorkeur in Bedrijfskunde, Supply Chain, Data Analytics of een vergelijkbare richting. Minimaal 5 jaar ervaring binnen Commercial Operations, Sales Operations, Process Improvement of Continuous Improvement. Uitgebreide ervaring met SAP en sterke kennis van commerciële processen, pricing en masterdata. Gevorderde kennis van Excel, Power Query, Power BI, Power Automate en Microsoft Copilot; ervaring met Databricks is een pré. Analytisch, zelfstandig en hands-on, met het vermogen om processen snel te doorgronden en praktische verbeteringen te realiseren. Uitstekende beheersing van de Nederlandse taal; ervaring binnen een FMCG-omgeving is een sterke pré. Overige informatie Solliciteer vandaag nog voor meer informatie over deze vacature. We kijken uit naar je sollicitatie!

The Company Our client is a leading global biotechnology organization dedicated to developing innovative cell therapies that transform the lives of patients with serious diseases. Operating in a highly regulated GMP environment, the company is committed to delivering high-quality medicines through advanced manufacturing, operational excellence, and continuous innovation. Role Overview We are seeking a Cell Therapy Manufacturing Specialist to support the manufacturing of clinical and commercial cell therapy products in a GMP-regulated cleanroom environment. As part of the Production Team (PT) or Production Support Team (PST), you will play a key role in ensuring safe, compliant, and efficient manufacturing while contributing to continuous process improvements. Key Responsibilities Perform manufacturing and production support activities in a GMP-regulated cleanroom environment. Follow SOPs and cGMP regulations while accurately completing batch records and manufacturing documentation. Support aseptic processing, material preparation, cryopreservation, visual inspection, and sample handling. Troubleshoot manufacturing and equipment issues while supporting deviation investigations and change management. Collaborate with Production, Quality Assurance, Quality Control, and Material Management teams to ensure efficient manufacturing. Drive continuous improvement initiatives to enhance product quality, compliance, and operational efficiency. Requirements MBO/MLO/HBO (Level 4+) qualification in Life Sciences, Biotechnology, or a related scientific discipline. Experience in a GMP-regulated pharmaceutical, biotechnology, or advanced manufacturing environment. Knowledge of aseptic processing, cleanroom operations, and GMP documentation. Strong problem-solving, communication, and teamwork skills with excellent attention to detail. Fluent in English and willing to work rotating shifts, including weekends. Other Information If you are interested in this opportunity and would like to apply, please submit your application using the apply button below. For further information about this role, feel free to get in touch.

The Company A global pharmaceutical manufacturing organization focused on innovation, quality, and operational excellence. The company operates highly automated production facilities within a GMP regulated environment and invests heavily in advanced manufacturing technologies and continuous improvement initiatives. Role Description As an Automation Operator, you will be responsible for operating, monitoring, and optimizing automated production lines to ensure safe, efficient, and compliant manufacturing processes. This role combines technical troubleshooting, equipment operation, and GMP documentation while supporting process improvements and production performance. Responsibilities - Operate and monitor automated production equipment according to SOPs and GMP standards - Perform troubleshooting and root cause analysis on automated systems - Adjust machine parameters and settings to improve operational performance - Record and verify production data within SAP and MES systems - Monitor process performance and report deviations when required - Complete batch records, production logs, and GMP documentation accurately - Participate in cross functional problem solving and triage meetings - Execute equipment startup and shutdown procedures - Perform routine cleaning activities according to production schedules - Identify and support continuous improvement opportunities - Contribute to Lean Manufacturing initiatives - Ensure smooth shift handovers and effective communication - Maintain a safe and compliant production environment Requirements - Minimum 3 years of experience in a similar manufacturing or production role - Experience working within automated production environments - Fluent English communication skills - Experience following SOPs and GMP procedures - Knowledge of assembly and packaging processes - Experience using SAP and MES systems - Strong troubleshooting and analytical skills - Experience with Lean Manufacturing and Six Sigma principles - Technical understanding of mechatronics, pneumatics, and electronics - Ability to understand and explain the function of sensors, valves, bearings, and automation components - Willingness to work in rotating 3-shift or 5-shift schedules. - Technical education such as MBO, VAPRO B, or equivalent Other Information - Shift based work environment - Pharmaceutical manufacturing environment - GMP regulated facility - Strong focus on automation, quality, and continuous improvement

Company Our client is an international life sciences organisation operating in a highly regulated environment. They develop and manufacture innovative therapies and are committed to high standards in quality, compliance, and continuous improvement. The working environment is dynamic, fast-paced, and strongly focused on teamwork and operational excellence. Job Description For a manufacturing site in Hoofddorp, we are looking for a GMP Cell Therapy Production Specialist to support the production of clinical and commercial cell therapy products in a cleanroom setting. This role sits within either the production team or the production support team and is focused on safe, compliant execution of manufacturing activities, accurate documentation, and proactive support of process improvements. Responsibilities The GMP Cell Therapy Production Specialist will be responsible for: - Executing manufacturing and/or production support activities in a GMP-regulated cleanroom environment (including aseptic areas). - Following SOPs and cGMP requirements and completing batch records accurately and on time. - Performing activities such as material preparation, material decontamination, and transferring materials and documentation into cleanroom areas. - Supporting aseptic processing steps and ensuring consistent process execution to meet quality standards. - Performing visual inspection activities and supporting cryopreservation activities when required. - Handling sample submission and coordination with Quality Control / sample management. - Supporting deviation investigations and contributing to change management activities. - Troubleshooting basic processing and equipment issues and escalating where needed. - Identifying opportunities for continuous improvement and supporting implementation of efficiency and quality improvements. - Working closely with cross-functional teams such as Production Support, Material Management, QA, and QC. Requirements - Education at MBO/MLO/HBO level (Level 4+) in Life Sciences or a related discipline. - Proven experience working in a GMP-regulated pharmaceutical, biotechnology, or similar manufacturing environment. - Comfortable working in full gowning requirements in an aseptic cleanroom environment. - Strong attention to detail and confidence with documentation and batch record execution. - Good skills in Microsoft Word and Excel; comfortable working with data. - Strong communication skills in English (Dutch is not required). - A hands-on mindset, willingness to learn, and the ability to adapt in a changing environment. - Willingness to work in a shift schedule (including weekends). - Vapro A/B or LITOP A/B is a plus. Other Information This role requires working in a cleanroom environment and following strict procedures at all times. Because the work involves blood products, vaccination against Hepatitis B is strongly recommended (candidates should already be vaccinated or be willing to get vaccinated). If you are interested and want to apply, please submit your application via the apply button below and contact me.