Regulatory Affairs Specialist, Rijswijk, Zuid-Holland

The Company A leading global biotechnology organization operating in a highly regulated GMP environment, focused on high-quality manufacturing, compliance, and continuous improvement. Role Overview We are seeking a Technical Operator (Automated Lines) to operate and optimize highly automated production systems, ensuring efficient, compliant, and high-quality manufacturing. The role combines technical expertise with operational discipline to maintain equipment performance and support continuous improvement. Key Responsibilities - Operate and monitor automated production equipment according to SOPs and GMP standards. - Perform troubleshooting, root cause analysis, and machine parameter adjustments. - Maintain accurate GMP documentation and production data in SAP/MES systems. - Perform equipment set-up, close-down, and cleaning activities. - Participate in triage and problem-solving with QA, M&E, and Production teams. - Support Lean and continuous improvement initiatives and ensure effective shift handovers. Requirements - Minimum 3 years of experience in a similar production role, preferably in assembly and packaging. - Proven experience in an automated production environment, preferably pharmaceutical or food manufacturing. - Technical education such as MBO / VAPRO B or equivalent. - Strong knowledge of GMP, SOPs, SAP/MES, and manufacturing processes. - Experience with Lean, Six Sigma, RCA, 5 Why, Kaizen, Poka-Yoke, TPM, SMED, or Fishbone. - Knowledge of mechatronics, pneumatics, and/or electronics. - Fluent in English and willing to work shifts and commute. - Strong technical, analytical, problem-solving, and communication skills. Other Information If you are interested and would like to apply, please submit your application using the apply button below. For further information about this opportunity, feel free to get in touch.

The Company Our client is one of the leads from the Biotechnology industry who try to improve patients’ lives, by distributing their medicines to hospital and pharmacies in 100 different countries in the world, to over 10 million patients, in Europe, Turkey, Middle East and Africa Regions. Role Description As a Production Operator, you will be responsible for operating and maintaining semi-automated production and packaging lines within a GMP-regulated manufacturing environment. You will ensure production processes run safely, efficiently, and in compliance with quality standards while supporting continuous improvement initiatives and minimizing production downtime. Responsibilities Run and oversee production machines to keep operations running smoothly. Prepare equipment for new production batches and switch products when needed. Spot and fix minor machine issues to reduce downtime. Enter and update production records using the company's systems. Help investigate production issues and support practical solutions. Suggest ideas to improve efficiency, quality, and daily operations. Follow safety, quality, and company procedures at all times. Work closely with your team to achieve daily production goals. Requirements A technical background or hands-on experience in a production or manufacturing environment. Previous experience working with production machinery or automated equipment. Comfortable troubleshooting basic machine or process issues. Experience in industries such as pharmaceuticals, biotechnology, food, medical devices, or other regulated environments is a plus. Familiarity with production systems such as SAP or similar software is an advantage. A proactive mindset with a willingness to learn and improve processes. Good communication skills in English. Willingness to work rotating 3-shift or 5-shift schedules. Other Information This is an excellent opportunity to join a global, high-tech manufacturing environment where you'll work with advanced automation technologies while developing your technical skills and career. A competitive salary, shift allowances, bonus, 13th-month salary, holiday allowance, and excellent development opportunities are offered. Apply to our vacancy for more information. We look forward to hearing from you!

Company Our client is a large, international organisation in a highly regulated life-sciences environment. They run complex operations where quality, compliance, and reliable supply processes are critical. The culture is structured, collaborative, and focused on continuous improvement. Job Description For our client, we are looking for a Logistics Process Owner (Materials Supply) to take ownership of key material supply and replenishment processes at their site in Leiden. This role sits close to operations and has direct impact on manufacturing performance, so it requires someone who is hands-on, detail-focused, and confident working in a compliance-driven setting. Responsibilities -Own and improve end-to-end material supply and replenishment processes for the site -Analyse current logistics workflows to identify bottlenecks, risks, and improvement opportunities Develop, maintain, and review SOPs and process documentation in line with GDP/GMP expectations -Collaborate with warehouse, operations, and other cross-functional stakeholders to ensure smooth material flow -Define, track, and report KPIs to monitor process performance and drive improvements -Support continuous improvement initiatives using Lean / operational excellence principles -Use systems and data tools to monitor performance and support decision-making (e.g., ERP and reporting tools) Requirements -Several years of hands-on experience in logistics/materials supply within a regulated manufacturing environment (GDP/GMP) -Strong process ownership mindset: able to build, implement, and sustain processes (not only analyse) -Experience writing and maintaining procedures / SOPs -Lean / continuous improvement skills (Lean Six Sigma is a strong advantage) -Comfortable working with ERP systems and data/reporting tools (SAP knowledge is a plus) -Strong English communication skills: Dutch is a plus -Able to work full-time on-site in Leiden 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 leading organisation in the life sciences and advanced manufacturing sector, operating a highly regulated production and distribution environment. The site in Leiden plays a critical role in supporting manufacturing operations, with strong focus on quality, compliance, and continuous improvement. Job Description We are looking for a Logistics Process Specialist  to take ownership of the end-to-end material supply processes at a biotherapeutics manufacturing site in Leiden. This is a hands-on role focused on keeping material replenishment running smoothly from warehouse to production, ensuring GMP/GDP compliance, and driving process improvements that directly impact day-to-day operations. Responsibilities - Own and manage material supply and replenishment processes from warehousing through to production areas, ensuring continuity and operational stability. - Analyse current logistics workflows to identify inefficiencies, risks, and bottlenecks, then implement practical improvements. - Develop, update, and maintain SOPs and supporting documentation, ensuring timely reviews and a strong compliance-first approach. - Collaborate closely with warehouse, distribution, site operations, and broader planning stakeholders to resolve issues and align on process changes. - Define, track, and report KPIs to monitor performance and support data-driven decision-making. - Identify opportunities to improve systems and ways of working, leveraging tools such as SAP and reporting/analytics platforms. - Drive continuous improvement initiatives using Lean / operational excellence methods, with a focus on “getting things done” and delivering measurable results. Requirements - Minimum 3+ years of hands-on experience in logistics/warehouse/manufacturing environments, ideally within a regulated setting (GMP/GDP). - Strong process ownership mindset (this is not a planning role) with proven experience improving operational processes. - Confident technical writer with experience creating and maintaining procedures and controlled documentation. - Lean / Six Sigma or operational excellence experience (certification preferred). - Working knowledge of supply chain/logistics systems and tools (e.g., SAP ECC, Excel; exposure to Tableau/Power BI is beneficial). - Strong English communication skills; Dutch is a nice-to-have. - Comfortable working fully on-site in Leiden. Other Information This role is based on-site in Leiden, Netherlands, and the client strongly prefers five days per week on-site due to the operational nature of the work and on-site materials handling. 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 food production business with a modern production and packaging operation. Quality, food safety, and efficiency are central to everything they do, and the site runs in a structured shift environment with clear procedures and teamwork at its core. Job Description We are looking for an Allround Packaging Line Operator to join the production and packaging team. In this role, the candidate will operate, set up, change over, and monitor multiple packaging lines and related equipment, ensuring frozen products are packed safely, correctly, and ready for dispatch. They will work closely with packing staff, support operators, and supervisors to keep production running smoothly and to deliver planned orders on time. Responsibilities - Set up, operate, change over, and monitor packaging lines, carton forming equipment, and palletising installations. - Carry out quality and safety checks, recording results in line with internal procedures. - Monitor product flow and take action quickly when issues, deviations, or breakdowns occur. - Resolve minor technical issues independently and involve the technical team when required. - Coordinate day-to-day work on the assigned line(s) with packing staff and support operators. - Ensure products are processed, packed, and palletised correctly according to the production schedule. - Maintain high standards of order, cleanliness, food safety, quality, and safe working practices. - Take an active role in shift handovers, ensuring clear communication with colleagues and team leaders. Requirements - LBO/MBO level of working and thinking, with at least 2 years of relevant experience. - Experience working with packaging lines and handling basic equipment faults. - Good understanding of food safety standards such as HACCP, allergens, and safety instructions. - Willingness to work in a 3-shift rota (07:15–15:15, 15:15–23:15, 23:15–07:15). - Practical, organised, and comfortable coordinating with colleagues on the line. - Open to on-the-job training. Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me.  

About the Company Our client is a global biopharmaceutical organization with a highly regulated manufacturing environment. The production site focuses on the safe and consistent manufacturing and packaging of medicines, with a strong emphasis on quality, compliance and operational excellence. Role Description As a Technical Operator – Manual Lines, you will execute manual production and packaging activities within a GMP-regulated manufacturing environment. You will work according to strict procedures and SOPs, perform quality checks and ensure accurate documentation throughout the production process. With a strong focus on consistency, accuracy and compliance, you will contribute to a safe and efficient production flow while working closely with your team. Key Responsibilities Execute manual production and packaging activities according to SOPs and established procedures. Perform in-process quality checks and ensure products meet applicable requirements. Complete batch records, logs and other GMP documentation accurately and on time. Identify and report deviations and quality issues and support their resolution. Participate in triage and problem-solving activities with Production and QA. Perform production set-up and close-down activities. Execute daily, weekly and monthly cleaning activities. Maintain a safe, clean and compliant working environment. Perform repetitive manual production tasks with consistency and accuracy. Collaborate with colleagues to maintain a smooth and efficient production process. Requirements Basic understanding of GMP, SOPs and production processes. Strong quality focus and attention to detail. Good manual dexterity and ability to maintain a consistent work tempo. Highly disciplined and comfortable working according to strict procedures. Reliable, accurate and consistent in repetitive production activities. Strong compliance mindset. Fluent in English. Willingness to work in a 2-shift system and commute to Breda. Experience with ERP systems such as SAP/MES is an advantage.

About the Company Join a leading international pharmaceutical manufacturer where medicines are labeled, assembled, stored, and distributed worldwide. Working in a highly automated GMP manufacturing environment, you'll help ensure reliable production while contributing to continuous improvement and operational excellence. Role Description As a Technical Operator – Automated Lines, you will operate, monitor, and optimize fully automated production equipment to ensure safe, efficient, and compliant manufacturing. You will play an important role in troubleshooting technical issues, improving equipment performance, and maintaining high quality standards within a regulated production environment. Key Responsibilities Operate and monitor fully automated production and packaging lines Perform machine set-ups, changeovers, line clearances, and cleaning activities Troubleshoot equipment and process issues using structured problem-solving methods Perform minor maintenance and mechanical or parameter adjustments Record production activities and batch data in SAP and MES systems Support deviation investigations and production triage activities Perform Root Cause Analyses (RCA, 5 Why) and implement corrective actions Contribute to Lean and Continuous Improvement initiatives Ensure compliance with GMP, safety, and quality requirements Support optimal equipment performance and production efficiency Requirements MBO degree or equivalent technical education Experience operating fully automated production, assembly, labeling, or packaging lines Strong troubleshooting and analytical skills Experience with Root Cause Analysis (RCA), 5 Why, or similar methodologies Experience within a regulated manufacturing environment (GMP preferred) Experience with SAP and/or MES systems Knowledge of Lean or Continuous Improvement methodologies is an advantage Proactive, quality-focused, and able to work independently Fluent in English Willing to work in 3-shift and future 5-shift rotations   Contract Details Full-time position Shift allowances and competitive employment conditions Extensive learning and development opportunities Modern manufacturing environment with strong focus on employee well-being

Over het bedrijf Onze opdrachtgever is een internationale farmaceutische organisatie die actief is binnen een sterk gereguleerde omgeving, met een sterke focus op productkwaliteit, compliance en continue verbetering binnen productie- en kwaliteitsprocessen. Functieomschrijving Als QA Officer ondersteun je diverse Quality Assurance-activiteiten binnen een GMP-gereguleerde farmaceutische of biotechomgeving. Je draagt bij aan het behandelen van afwijkingen en CAPA's, root cause investigations, validatie- en kwalificatieactiviteiten en het beoordelen van kwaliteitsdocumentatie. Je werkt nauwkeurig volgens vastgestelde kwaliteitssystemen en schakelt effectief met verschillende interne en cross-functionele stakeholders. Belangrijkste verantwoordelijkheden Ondersteunen bij het behandelen en onderzoeken van GMP-afwijkingen. Bijdragen aan het opstellen, implementeren en opvolgen van CAPA's. Ondersteunen van root cause investigations met passende onderzoeksmethodieken. Deelnemen aan validatie- en kwalificatieactiviteiten. Beoordelen van GMP-documentatie op juistheid en compliance. Ondersteunen van Quality Assurance-activiteiten binnen farmaceutische of biotechproductie. Samenwerken met verschillende afdelingen rondom kwaliteits- en compliancevraagstukken. Zorgdragen voor een correcte en volledige documentatie van kwaliteitsactiviteiten. Functie-eisen Een relevante bacheloropleiding of gelijkwaardig niveau binnen een wetenschappelijke, farmaceutische of technische richting. Aantoonbare ervaring binnen een GMP-gereguleerde Sterke ervaring met deviations, CAPA's en root cause investigations. Ervaring met validatie en kwalificatie. Ervaring met het beoordelen van GMP-documentatie. Goede kennis van GMP-principes en kwaliteitssystemen. Vloeiende beheersing van Nederlands en Engels, zowel mondeling als schriftelijk.

About the Company Our client is an international food production organization specializing in frozen food products. Within a structured production and packaging environment, the organization focuses on delivering safe, high-quality products while maintaining efficient production processes and strong food safety standards. Role Description As an All-round Packing Operator, you will be responsible for operating, setting up, changing over and monitoring various packaging, box forming and palletizing systems. You will use your technical knowledge to resolve minor technical issues, monitor product quality and ensure a smooth production flow. Working closely with packing staff, assistant operators and supervisors, you will contribute to safe, efficient and high-quality production in a 3-shift environment. Key Responsibilities Set up, operate, change over and monitor packaging, box forming and palletizing systems. Perform quality and safety checks and accurately record results. Monitor product flow and make adjustments when deviations or malfunctions occur. Resolve minor technical breakdowns and involve the Technical Service when required. Coordinate daily activities with packing staff and assistant operators on assigned lines. Ensure correct processing, packaging and palletizing according to the production schedule. Follow applicable food safety, quality and hygiene procedures. Contribute to an orderly, clean and safe working environment. Participate actively in shift handovers and communicate relevant information clearly. Support smooth production and contribute to achieving planned production orders. Requirements At least 2 years of relevant experience in a production or packaging environment. Knowledge of HACCP and Food Defense. Experience or ability to provide and follow safety instructions. Experience with or willingness to participate in on-the-job training. Knowledge of allergens and food safety requirements. Technical understanding and a hands-on approach to resolving minor breakdowns. Able to work effectively with colleagues in a production and shift environment. Structured and quality-focused approach to working. Willingness to work in a 3-shift system: 07:15–15:15, 15:15–23:15 and 23:15–07:15.