Documentation Specialist, Hoofddorp, Noord-Holland

Company A leading organization in the pharmaceutical industry dedicated to the development and manufacturing of Small Molecule drug products. They prioritize innovation, quality, and regulatory compliance to deliver high-quality medicines to patients worldwide. Job Description We are seeking an experienced Senior Project Manager to lead and oversee large-scale Small Molecule drug product technology transfers across manufacturing sites. The role involves managing key projects from start to finish, ensuring timely complaints, and high-quality transfer execution to support the company's strategic growth. Responsibilities -Lead multiple Small Molecule technology transfer projects, ensuring smooth site-to-site transfers. -Oversee project timelines, risks, and milestones via dashboards and reporting tools. -Collaborate closely with Manufacturing, Quality, Regulatory, Supply Chain, Procurement, and other teams to align project goals and resolve issues. -Develop and maintain project governance, provide best practices, and coach project teams and sponsors. -Act as the primary contact for manufacturing sites and global functions, fostering strong relationships and clear communication. -Support regulatory submissions related to transfers and ensure compliance with GMP standards. -Contribute to continuous improvement of transfer processes and methodologies, driving best practices across regions. -Provide technical expertise and support for resolving transfer-related challenges. -Perform additional duties as assigned by management. Requirements -Bachelor’s degree or higher in Engineering, Chemistry, Biology, or a relevant scientific discipline. -Over 5+ years of experience in technology transfer, product development, or manufacturing operations within the pharmaceutical industry. -Extensive knowledge of Small Molecule drug product types, including liquids, ointments, creams, sterile injectables, and powders. -Proven ability to manage complex projects, with experience using enterprise project management tools like MS Project. -Strong knowledge of GMP regulations and regulatory processes, especially for EU and FDA standards. -Excellent stakeholder management, communication, and leadership skills. -Fluent in English, with additional language skills (e.g., German or French) considered an advantage. -Willingness to travel internationally approximately 10-20%. 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 global pharmaceutical organization focused on innovation, scientific excellence, and the reliable delivery of high-quality medicines. The organization operates across international manufacturing sites and maintains strong standards for GMP, regulatory compliance, and operational excellence. Role Description As an Associate Director, Technology Transfer Execution, you are responsible for leading Small Molecule technology transfer projects across global manufacturing sites, managing transfer execution from planning through completion while ensuring projects are delivered on time, in compliance with GMP and regulatory requirements, and to the required quality standards. You will work closely with Manufacturing, Quality, Regulatory Affairs, Supply Chain, Technical teams, CMOs, and global stakeholders to ensure successful project execution and alignment. Responsibilities - Lead and coordinate multiple Small Molecule technology transfer projects across manufacturing sites. - Manage project timelines, milestones, risks, deliverables, and governance. - Coordinate activities between donor and receiving sites and ensure effective stakeholder alignment. - Work cross-functionally with Manufacturing, Quality, Regulatory, Supply Chain, and Technical teams. - Support GMP compliance, process validation, qualification, change controls, deviations, and regulatory documentation. - Act as a key contact for manufacturing sites, global stakeholders, and CMOs. - Provide guidance, coaching, and problem-solving support to transfer teams. - Drive continuous improvement of technology transfer processes and best practices. - Communicate project progress, risks, and challenges to senior stakeholders. - Travel internationally approximately 10–20% of the time. Requirements - Bachelor’s degree in Engineering, Chemistry, Biology, or a related technical/scientific field. - 10+ years of experience in Technology Transfer, Product Development, Manufacturing Operations, or Technical Operations within pharmaceuticals. - Strong experience with Small Molecule pharmaceutical products and manufacturing processes. - Strong knowledge of GMP and EU/FDA regulatory requirements. - Experience with technology transfer, process validation, qualification, change control, and deviation management. - Strong project management and stakeholder management skills. - Experience working in global, cross-functional, and matrix environments. - Excellent English communication, negotiation, and influencing skills. - Proficiency with MS Project and Microsoft Office; SAP knowledge is an advantage. - Willingness to travel internationally 10–20%. 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 organization committed to maintaining the highest standards in quality and compliance within their regulated operations. They focus on ensuring safe and effective products through meticulous documentation and adherence to GMP guidelines. Role Description As a QA Documentation Specialist, you are responsible for verifying the accuracy and completeness of controlled batch documents and labels, ensuring compliance with quality standards and regulatory requirements, and supporting continuous improvement of documentation processes. Responsibilities - Verify controlled batch documents and label packages, including final product labels, in accordance with cGMP standards. - Confirm the accuracy and completeness of QA-issued documents and logbooks. - Ensure timely use and proper management of GMP materials and consumables, informing the responsible personnel as needed. - Identify and escalate compliance issues within the controlled issuance process. - Support initiatives aimed at improving documentation procedures. - Investigate deviations related to controlled document issuance and develop effective corrective action plans. - Perform additional duties as assigned, delegating tasks to qualified team members when necessary. - Prioritize tasks to meet deadlines, demonstrating strong attention to detail and accuracy. - Communicate effectively with colleagues at all levels, including senior stakeholders, and cross-train peers on documentation procedures. - Maintain advanced technical knowledge of GMP processes and ensure clear presentation of documentation operations and guidelines. Requirements - HBO or WO level education. - At least 2 years of experience managing documents in a regulated environment. - Strong command of English communication, both written and verbal. - Positive attitude and a detail-oriented approach. - Ability to work within a structured schedule, including working on weekends in a rotational pattern every six weeks, with adequate rest days. Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me.

The Company Our client is a well-known global dairy cooperative with over 150 years of experience in delivering high-quality dairy products and nutritional solutions worldwide. Role Description As a Customer QA Manager, you’ll act as the key quality partner for customers, managing complex quality topics and translating customer requirements into practical internal solutions. You’ll work closely with QA, R&D, Regulatory, Operations and Sales while driving customer satisfaction and continuous improvement. Responsibilities - Serve as the main point of contact for customer quality inquiries and issues - Lead and coordinate complex customer cases and quality requests - Translate customer quality requirements into internal standards and ensure alignment across Operations, R&D, Regulatory, and Sales teams - Build and maintain strong relationships with key customer stakeholders to foster long-term partnerships based on trust - Ensure products and processes meet internal standards, regulatory requirements, and customer expectations - Analyse customer feedback and quality data to identify trends and implement continuous improvements - Drive initiatives for quality assurance and innovation based on customer insights Requirements - Master’s degree in Food Technology, Life Sciences, or a related field - Minimum of 3 years experience in Quality Assurance, preferably in the food, ingredients, or FMCG industries - Proven track record in a customer-facing QA role with practical, hands-on experience - Strong knowledge of food safety, quality systems, and relevant regulations - Excellent stakeholder management and communication skills, capable of influencing at different levels - Analytical, structured, and results-oriented mindset - Digital literacy, including experience with CRM systems like Salesforce (a plus) Proactive, capable of managing multiple priorities in a fast-paced environment - Fluent in Dutch and English Other Information Apply to our vacancy for more information. We look forward to hearing from you!

Company Our client is a global organisation operating in a highly regulated pharmaceutical manufacturing environment. The site combines production and quality expertise to ensure products are made safely, consistently, and in full compliance with GMP and internal quality standards. The culture values ownership, clear documentation, and practical collaboration between Quality and Production. Job Description We are looking for a Deviation Investigator to support a production organisation by managing deviations and leading quality investigations to timely closure. The focus of this role is on quality-system investigations rather than routine production work. The successful candidate will be analytical, structured, and confident working independently while partnering closely with Production stakeholders. Responsibilities - Write, manage, and coordinate deviations from start to closure. - Lead quality investigations, including defining scope, gathering evidence, and documenting findings. - Perform root cause analysis and support the definition and follow-up of corrective and preventive actions (CAPAs). - Work closely with Production teams to clarify facts, challenge assumptions when needed, and keep investigations moving. - Ensure investigation files are complete, traceable, and compliant with GMP and internal quality standards. - Review relevant documentation such as SOPs, batch records, and protocols to support investigations and decisions. - Support quality-related questions from the production organisation and provide clear guidance on deviation handling. - Contribute to continuous improvement initiatives based on deviation trends, audit observations, and investigation outcomes. - Participate in meetings and collaborate with cross-functional stakeholders to ensure alignment on quality topics. Requirements - Proven experience in the pharmaceutical industry (mandatory). - Hands-on experience with deviations and investigations, including root cause analysis and driving actions to closure. - Strong understanding of GMP and quality systems, with a high standard for documentation. - Ability to work independently, prioritise effectively, and deliver under time pressure. - Strong communication skills and confidence working closely with Production teams. - Professional English (spoken and written). - Experience in sterile/aseptic manufacturing is a strong advantage. -Temporary Full-Time Contract (3 Months) Other Information This role requires strong on-site presence, especially during the initial phase, due to the hands-on nature of documentation and stakeholder interaction. If you are interested and want to apply, please submit your application via the apply button below and contact me.

The Company A global leader in nutrition and food ingredients, supplying high quality solutions to customers across the food, beverage, and health sectors. The organization operates internationally and focuses on innovation, quality, sustainability, and customer satisfaction. About the Role We are seeking a senior Customer QA Manager to act as the primary quality partner for customers across Europe. In this role, you will bridge the gap between customer expectations and internal quality standards, ensuring product quality, compliance, and customer satisfaction. You will manage complex customer quality topics, build strong relationships, and drive continuous improvement initiatives across the business. Responsibilities Act as the main Quality Assurance contact for customers Lead and coordinate complex customer quality cases and escalations Translate customer quality requirements into internal standards and processes Ensure compliance with customer requirements and applicable regulations Analyse customer feedback and quality data to identify improvement opportunities Drive continuous improvement initiatives within Customer QA Represent quality during customer meetings and audits Support the development and execution of Customer QA strategy Requirements Master's degree in Food Technology, Life Sciences, or a related field Minimum 5 years of Quality Assurance experience Previous experience in a customer facing QA position Strong knowledge of food safety and quality management systems Experience within food, ingredients, dairy, or FMCG industries Strong stakeholder management and communication skills Ability to challenge and influence customers and internal stakeholders Experience working with customer complaints and quality topics Fluent in Dutch and English Other Information Apply to our vacancy for more information. We look forward to hearing from you!  

The Company A leading pharmaceutical manufacturing organization focused on producing high quality medicines in a highly regulated environment. The company emphasizes quality, compliance, continuous improvement, and operational excellence across its production activities. About the Role This role is responsible for supporting and maintaining quality assurance activities within pharmaceutical manufacturing operations. The position focuses on ensuring GMP compliance, investigating deviations, driving CAPA initiatives, and supporting continuous improvement efforts. The successful candidate will work closely with production teams to enhance quality systems and maintain regulatory standards. Responsibilities -Write and manage production deviations and quality events -Monitor manufacturing processes and identify deviations from established procedures -Investigate quality issues, complaints, and non-conformances -Perform root cause analysis and develop CAPA plans -Support compliance investigations and quality improvement initiatives -Review SOPs, validation protocols, production documentation, and batch manufacturing records -Ensure compliance with GMP and company quality standards -Recommend improvements related to product quality, safety, health, and environmental standards -Participate in cross-functional quality and compliance projects -Provide quality related guidance and support to manufacturing teams -Maintain accurate documentation and reporting of quality activities Requirements -Master's degree or equivalent academic level -Degree in Pharmacy, Chemical Engineering, Life Sciences, or a related discipline -Experience in pharmaceutical manufacturing environments -Knowledge of aseptic pharmaceutical processes -Understanding of GMP regulations and quality systems -Experience with deviation management, investigations, and CAPA processes -Familiarity with production control systems -Strong analytical and problem-solving skills -Excellent written and verbal communication skills in English -Strong organizational and planning abilities -Ability to work effectively in a fast-paced environment -Experience reviewing manufacturing and validation documentation 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 global, innovation-driven organisation operating in a highly regulated manufacturing environment. The site focuses on reliable delivery of critical products and works to high quality and compliance standards. Teams collaborate closely across Manufacturing, Quality, Engineering and Technology to improve processes and keep operations running smoothly. Job Description We are looking for a Validated Systems Engineer to strengthen the Operations Technology team in Breda. This position sits at the intersection of digital technology and the production floor, helping to improve reliability, efficiency and compliance of packaging and labelling operations. The Validated Systems Engineer will support and improve a defined set of manufacturing systems (including SCADA and system integrations), working with site stakeholders and global teams to deliver practical solutions in a GMP-regulated environment. Responsibilities - Support the design, testing, qualification and change-control of manufacturing systems in line with GMP requirements and site procedures. - Maintain and troubleshoot a portfolio of operational manufacturing systems to ensure stable day-to-day performance. - Work with cross-functional stakeholders (Manufacturing, Quality, Engineering and Technology) to identify issues, root causes and improvement opportunities. - Support implementations and continuous improvement initiatives around packaging and labelling technology (e.g., SCADA, authentication solutions, mobile workstations and label-printing integrations). - Create clear documentation and train users on new or updated processes and systems. - Escalate and collaborate with internal experts and external technology partners when needed, and follow through until resolution. - Take increasing ownership of systems and deliverables over time, with guidance from experienced engineers and subject-matter experts. - Provide occasional flexibility outside standard hours to support planned go-lives or critical operational issues. Requirements - Bachelor’s degree in IT, Automation, Engineering or a comparable technical discipline. - Up to 4 years of relevant experience in manufacturing, IT/OT, automation or application support. - Structured approach to troubleshooting, documentation and continuous improvement. - Strong communication skills and ability to work effectively with both technical and operational teams. - Professional working proficiency in English. - Motivation to learn and work within GMP/validated manufacturing environments. - Nice to have: exposure to packaging/labelling systems, SCADA, industrial networks, system integrations, and/or qualification/testing/change control. Other Information This is an on-site role based in Breda, close to the manufacturing environment, combining project implementation with continuous improvement and operational support. If you are interested and want to apply, please submit your application via the apply button below and contact me.

Company: We are working with a leading global biopharmaceutical company dedicated to developing and manufacturing innovative medicines. Their Breda site focuses on delivering high-quality products through advanced manufacturing and technology solutions, with a strong emphasis on compliance, reliability, and continuous improvement. Job Description: The Manufacturing Systems Support Engineer plays a vital role in ensuring the reliability, efficiency, and compliance of labelling and packaging operations. This position involves working at the intersection of digital technology and manufacturing, supporting critical systems such as SCADA, automated label printing, and mobile workstations. It is an active, hands-on role suited for someone who enjoys technical problem-solving and seeing the direct impact of their work on manufacturing continuity. Responsibilities: •    Assist in the design, testing, qualification, and change management of manufacturing systems in accordance with GMP guidelines. •    Collaborate with internal teams across Breda and globally, as well as external technology partners, to identify improvement opportunities. •    Maintain, troubleshoot, and support a portfolio of manufacturing systems supporting both commercial and clinical production. •    Document processes and train staff on new technologies and systems. •    Identify recurring issues and contribute to solutions that improve system reliability, usability, and efficiency. •    Support and gradually take ownership of systems, projects, and continuous improvement initiatives under the guidance of experienced engineers. Requirements: •    Bachelor’s degree in IT, automation, engineering, or a related technical field. •    Up to 4 years of relevant experience in manufacturing, IT, automation, or application support. •    Strong troubleshooting, documentation, and continuous improvement skills. •    Good communication skills and ability to collaborate effectively with technical and operational teams. •    Willingness to learn GMP standards and manufacturing systems. •    Professional English proficiency. Other Information: If you are interested and want to apply, please submit your application via the apply button below and contact me. This role is based in Breda and requires on-site presence near the manufacturing environment. Flexibility outside standard working hours may occasionally be required to support project rollouts or critical operations.

The Company A reputable food manufacturing organization focused on producing high-quality food products in a safe, efficient, and well-organized production environment. The organization places strong emphasis on safety, quality, hygiene, technology, and continuous improvement.. About the Role The Production Supervisor will be responsible for managing a team and ensuring smooth and efficient production operations within one or more departments. The role focuses on safety, quality, production output, technical priorities, team development, and effective communication between shifts. Responsibilities Manage and coach a team of employees, providing clear direction and leading by example. Take operational responsibility for safety, quality, quantity, hygiene, and technology within one or more departments. Ensure production planning and targets are achieved while setting priorities for technical work. Analyse production complaints and identify causes to support effective corrective actions and improvements. Ensure effective shift handovers, contribute to work instructions, and maintain continuity between shifts. Requirements Proven experience managing and leading teams within a production or manufacturing environment. Strong understanding of production operations, with responsibility for safety, quality, hygiene, and output. Experience working with production planning and prioritising technical or operational activities. Strong problem-solving skills, including analysing production issues and identifying root causes. Strong coaching, communication, and leadership skills, with the ability to lead by example. Other Information Apply to our vacancy for more information. We look forward to hearing from you!