Quality Assurance Specialist, Haarlem, Noord-Holland

Company Our client is a leading organization in the pharmaceutical manufacturing industry, committed to maintaining the highest standards of quality in their production processes. They focus on ensuring product safety, compliance, and continuous improvement through innovative quality management practices. Job Description We are seeking a dedicated Senior Quality Assurance Specialist to join the team and support ongoing quality processes. The key focus of this role is to assist in reducing the current backlog of deviation investigations, with an emphasis on deviation handling and writing. The role involves working closely with production and the qualified person (QP) team to ensure compliance and quality standards are maintained, without participation in batch release activities. Responsibilities -Manage and resolve deviation reports, including investigating, writing, and documenting deviations. -Support the QA department in reducing deviation backlog and implementing quality improvements. -Review and approve master documents and specifications for product release. -Initiate and assess quality investigations, making informed decisions about product release or rejection. -Ensure timely completion of deviation reports (gDR/gLIR) and supervise corrective actions. -Oversee quality investigations to control risks in manufacturing processes. -Authorize and review stability studies and product quality reviews. -Prepare and manage inspections by government authorities and customers, ensuring compliance with regulations. -Handle complaints, coordinate recalls, and investigate root causes of product issues. -Develop and maintain relationships with external contacts related to quality concerns. -Provide functional leadership to QA team members by organizing work and promoting structured --working methods. Requirements -Minimum 5 years of experience in pharmaceutical quality assurance, with strong exposure to aseptic manufacturing and lyophilization. -Proven experience in deviation handling and investigation. -Solid understanding of aseptic processes and visual inspection of lyophilized products. -Good knowledge of pharmaceutical regulations (EU and US) and analytical methods. - Excellent command of English, especially for technical documentation. -Dutch language skills are a plus but not mandatory. -Experience with automated processes is preferred. -Strong problem-solving and decision-making skills with a result-oriented approach. Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me.  

Company Overview A leading biotechnology organization dedicated to developing innovative medicines that improve patient lives worldwide. With a diverse workforce of over 1,000 people from 38 countries, the company operates manufacturing, supply chain, marketing, and clinical research activities to serve millions of patients globally. Role Description We are seeking a proactive and detail-oriented Supply Chain Associate to join our Clinical Supply Operations team. In this role, you will support the end-to-end management of our clinical supply chain, ensuring the safe and timely delivery of investigational medicines to clinical sites across the globe. Responsibilities - Assist in managing the lifecycle of clinical supplies, from labeling and packaging to distribution and final disposal. - Support the coordination of product labeling, assembly, storage, and shipment activities in accordance with regulatory standards. - Collaborate with cross-functional teams including Regulatory Affairs, Manufacturing, and Clinical Operations to facilitate product launches and updates. - Maintain accurate documentation and track all supply activities within the relevant systems. - Support inventory management, tracking shipments, and resolving supply chain issues. - Participate in process improvement initiatives aimed at increasing efficiency and quality. - Manage specialized shipping requests, ensuring compliance with customs and safety regulations. - Assist with end-of-life activities for clinical trial materials and SKUs as needed. - Contribute to team projects by gathering data, preparing reports, and supporting stakeholder communication. Requirements - Bachelor’s degree or higher, preferably in a relevant field. - At least 2 years of experience in supply chain operations, preferably within the pharmaceutical or healthcare sector. - Fluency in English, both spoken and written. - Strong communication and organizational skills. - Experience working in an international or global supply chain environment. - Knowledge of regulatory standards related to clinical supplies is a plus. - Analytical mindset with good attention to detail. - Customer-focused, proactive, and capable of working independently as well as part of a team. - Tech-savvy with proficiency in supply chain systems and tools. Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me.  

Company overview Our client is a leading pharmaceutical company committed to delivering high-quality products through innovative processes and rigorous standards. They focus on continuous improvement and patient safety, maintaining excellence across all facets of their operations. Job description We are seeking a skilled Quality Engineer (Investigation Owner) to lead and manage quality investigations related to manufacturing processes, products, and systems. The ideal candidate will be responsible for identifying root causes of quality issues, driving corrective and preventive actions, and ensuring compliance with regulatory and internal standards. This role requires close collaboration with cross-functional teams to document findings, implement process improvements, and communicate effectively with stakeholders. Responsibilities •    Lead root cause investigations of non-conformances and quality issues, including managing CAPA records and change controls from initiation to completion. •    Review and support documentation associated with manufacturing processes and activities. •    Maintain and update procedures and quality records, ensuring compliance with regulatory requirements. •    Initiate and support risk mitigation initiatives and continuous quality improvement projects. •    Support formal escalation processes related to safety, product quality, and regulatory compliance risks. •    Conduct GEMBA walks regularly to observe GMP adherence, identify areas for improvement, and implement corrective actions. •    Assemble and lead teams for quality record management, escalating issues as needed, and maintaining high professional standards. Requirements •    HBO degree with a minimum of 5 years of experience as a Lead Investigator, Quality Engineer, or in a similar role within the pharmaceutical industry. •    Proficiency in English at B2 level. •    Intermediate proficiency in MS Office, routine data analysis skills, and familiarity with business applications at a specialist level. •    Proactive, organized, decisive, and able to work independently or in a team environment. •    Stress-resistant with the ability to remain calm under pressure. •    High accuracy, attention to detail, and a quality-oriented approach. •    Adaptable to changing priorities and proactive in addressing issues. •    Strong analytical thinking skills to deal with complexity, ask questions, analyze data, identify root causes, and develop innovative solutions. •    Effective at prioritizing tasks to meet deadlines and ensure timely results. •    Excellent stakeholder communication skills and ability to build strong relationships. Other Information This position is based in the Netherlands and offers an opportunity to work in a dynamic, regulated environment within the pharmaceutical sector. The role is ideal for candidates with a strong investigative mindset and a passion for maintaining high-quality standards.

The Company A global organization operating within the pharmaceutical and life sciences industry, focused on maintaining high quality standards across manufacturing, supply chain, and regulatory processes. The company works in a highly regulated environment where compliance, product quality, and patient safety are critical priorities. About the Role The NL CW Senior Associate QA is responsible for supporting Quality Assurance activities related to SAP Master Data and artwork approval processes. The role ensures compliance with GMP requirements while maintaining data integrity and operational excellence. This position works closely with cross functional teams including regulatory affairs, supply chain, master data specialists, and quality management to support business objectives and continuous improvement initiatives. Responsibilities Perform QA review and approval of SAP Master Data activities including critical value verification and Bills of Materials Review and approve artwork for medicinal products Author operational SOPs and Work Instructions Conduct QA review of SOPs and Work Instructions Participate in Quality Assurance projects and continuous improvement initiatives Support investigations and issue resolution activities Prepare weekly and monthly quality metrics reports Own and maintain departmental performance boards Monitor QA systems and recommend improvements Collaborate with Global Artwork Center, Master Data teams, Site SMEs, Regulatory Affairs, and QA Management Identify, evaluate, and resolve data integrity issues Ensure compliance with regulatory and quality standards Requirements Bachelor degree or equivalent qualification in Life Sciences or a related field Approximately 3 years of Quality Assurance or pharmaceutical manufacturing experience Knowledge of GMP, GDP, and/or GCP regulations Experience working within regulated pharmaceutical or medical device environments Excellent communication and stakeholder management skills Ability to work effectively under pressure Experience with SAP Master Data processes is advantageous Fluent English & Dutch language skills  

Job Vacancy — Senior Automation Engineer | Breda   About our client Our client is a global biotechnology company developing and manufacturing innovative medicines for patients worldwide. The Breda site is a large-scale manufacturing operation focused on the assembly, inspection, labeling and packaging of pharmaceutical products. The site operates in a highly regulated GMP environment, where reliable equipment, automation and data integrity are essential to maintaining safe, compliant and efficient production.   About the position We are looking for a Senior Automation Engineer to join the Equipment Engineering team in Breda. In this role, you will take ownership of the automation side of new and upgraded manufacturing equipment — from design and vendor testing through installation, qualification and operational handover. You will work closely with Engineering, Manufacturing, Maintenance, IT and external equipment suppliers to make sure automation systems are reliable, secure, compliant and ready for production. This is a hands-on role for someone who enjoys combining automation engineering, project execution and troubleshooting in a regulated manufacturing environment.   Responsibilities Lead the automation activities for new and upgraded manufacturing equipment. Review and develop automation design documentation, including URS, FDS, HDS and SDS. Support FAT, commissioning, testing and qualification activities. Work with PLC, HMI, SCADA, industrial PC and vision systems. Ensure equipment meets required automation, cybersecurity and data integrity standards. Support equipment integration with site systems, including the PI data historian. Develop and maintain backup/restore, parameter and audit-trail procedures. Support automation troubleshooting and provide on-floor hypercare during implementation. Assess preventive maintenance requirements and automation spare parts. Maintain equipment documentation and asset parameter lists. Train Maintenance, Engineering and relevant Operations teams. Report project progress and technical risks to project management. Support New Product Introduction (NPI) activities at the site.   Requirements Bachelor’s or Master’s degree in Automation Engineering, Industrial Automation, Industrial Information Systems or a related discipline. 5+ years of experience with automation/process control and information systems in pharmaceutical or biotechnology manufacturing. Proven experience with labeling and/or packaging equipment. Practical knowledge of PLC, HMI, SCADA, industrial PCs and vision systems such as Cognex. Experience working in a GMP/regulatory manufacturing environment. Experience delivering automation projects in cross-functional or international teams. Strong understanding of equipment implementation, testing and commissioning. Able to troubleshoot technical issues and translate them into practical solutions. Strong communication and stakeholder-management skills. Fluent English, written and spoken.

Company A leading global organization in the life sciences sector is expanding its manufacturing operations in the Netherlands. The site works in a highly regulated environment, with a strong focus on quality, compliance, and continuous improvement. The organization is investing in new and upgraded production and packaging equipment and is strengthening its engineering capabilities to support long-term operational readiness. Job Description For a production site in Breda, we are looking for an Equipment Automation Engineer to support the automation scope of new and upgraded manufacturing equipment. The Equipment Automation Engineer (Packaging & Inspection) will take ownership of automation deliverables across the full equipment lifecycle—design, installation, commissioning, and ongoing support—working closely with engineering, manufacturing, quality, and external equipment suppliers. Responsibilities - Leading automation activities for equipment projects in Device Assembly, Inspection, Labelling, and Packaging areas - Writing and/or reviewing key automation and engineering documentation (e.g., URS, FDS, HDS, SDS) - Supporting installation, testing, commissioning, and qualification activities (including vendor testing phases where needed) - Ensuring systems align with site and network security requirements (e.g., domain settings, firewall considerations) - Implementing internal automation standards for both hardware and software - Installing required monitoring tools and supporting data integrity assessments - Performing or supporting automation preventive maintenance assessments - Advising on automation spare parts and contributing to asset spare parts lists - Creating, testing, and maintaining backup/restore procedures and work instructions for configurable components - Creating parameter management and audit trail review work instructions - Creating and updating Asset Parameter Lists (APLs) - Supporting integration to a PI data historian (or similar data platform) - Training maintenance/engineering teams and relevant operators on automation-related topics - Providing “hypercare” support on the shop floor after implementation as required - Providing progress updates and reporting to (project) management and key stakeholders Requirements - Bachelor’s or Master’s degree in Industrial Automation Engineering, Industrial Information Systems, or similar - At least 5 years’ experience delivering automation / process control / information systems support in a regulated manufacturing environment (biotech, pharma, or similar) - Proven experience running workstreams independently within cross-functional project teams - Experience with labelling and packaging equipment is essential - Working knowledge of industrial automation technologies such as PLC, HMI, SCADA, industrial - PCs, and vision systems (e.g., Cognex) - Strong understanding of working in regulated environments (e.g., GMP) - Fluent in English (written and spoken) - Willingness to occasionally work outside office hours when project activities require it Other Information This position is based on-site in Breda, the Netherlands, and offers the opportunity to contribute to high-impact equipment projects within a modern, regulated production environment.

Company  A leading organization within the manufacturing sector dedicated to delivering high-quality, innovative solutions. The company values technical excellence, teamwork, and continuous improvement to ensure operational success and sustainability. Job Description We are seeking a proactive and experienced Senior Automation Engineer to join our dynamic team in Breda. This role focuses on overseeing automation systems involved in the installation, commissioning, and lifecycle management of advanced manufacturing equipment, particularly in device assembly, inspection, labeling, and packaging areas. The ideal candidate will ensure equipment reliability, security, and optimal performance through expert automation practices. Responsibilities Manage automation aspects of new equipment installations and upgrades, ensuring alignment with project timelines. Support New Product Introduction (NPI) and coordinate test phases at equipment vendors and on-site. Oversee automation design, including review and creation of technical documents such as URS, FDS, HDS, and SDS. Support equipment installation, testing, commissioning, and validation, considering network security settings. Ensure equipment security using Amgen standards and support the connection to data historians like PI. Participate in FAT, commissioning, and qualification activities. Conduct automation preventive maintenance and data integrity assessments. Advise on spare parts and develop asset spare parts lists for automation equipment. Create backup and restore procedures, parameter review protocols, and audit trail review procedures. Support automation training for Maintenance, Engineering, and Operators. Provide operational hypercare support and update documentation to maintain operational effectiveness. Requirements Bachelor’s or master’s degree in Industrial Automation Engineering or related fields. Minimum of 5 years’ experience in process control and information systems support within biopharmaceutical or pharmaceutical manufacturing environments. Proven ability to execute independent projects in cross-functional, global teams. Hands-on experience with labelling and packaging equipment, including PLC, HMI, SCADA, Cognex vision systems, and industrial PCs. Familiar with regulated environments (GMP, OSHA, EPA). Strong knowledge of automation standards, network security, and data management. Excellent communication skills in English, both written and spoken. Ability to work outside regular hours when necessary. 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 public organization dedicated to ensuring the safety, accessibility, and sustainability of national infrastructure. They are involved in large-scale projects that contribute to maintaining and improving key transport connections and public assets across the Netherlands. Job Description We are seeking an experienced Senior Project Controls Coordinator to support the management of maintenance and renewal projects for bridges in Zeeland. This role involves establishing and maintaining effective project control processes, providing vital oversight, and ensuring projects are delivered on time, within scope, and within budget. The successful candidate will be instrumental in building the project controls framework from the ground up, contributing to the safe and efficient operation of bridge infrastructure. Responsibilities -Develop, implement, and oversee project control systems across multiple bridge maintenance and renewal projects. -Ensure accurate tracking and reporting of project scope, schedule, finances, risks, quality, and documentation. -Provide clear insights and highlight potential issues or blind spots within project controls. -Collaborate with project teams to establish aligned processes for planning, budgeting, risk management, and quality assurance. -Translate findings into actionable recommendations for decision-making. -Liaise with colleagues to maintain high standards of project control quality and timeliness. -Lead and motivate a team of professionals, fostering a culture of accountability and continuous improvement. -Build the project controls framework in a relatively new environment, setting up processes and workflows from scratch. -Monitor project performance, anticipate challenges, and implement corrective measures where needed. -Ensure all project control activities comply with applicable frameworks and organizational standards. Requirements -Minimum of 5 years’ experience in project control or management. -Relevant higher education qualification (HBO level) in finance, economics, or business administration. -Solid understanding of the IPM model and the role of project controls within infrastructure projects. -Proven ability to establish project control processes independently from the ground up. -Strong leadership skills and experience in managing project control teams. -Excellent analytical skills, with the ability to identify and address control gaps. -Effective communicator, capable of working across disciplines and levels of the organization. -Flexibility to work on-site in Middelburg every Tuesday and adapt to project needs. -Proficiency in Dutch language. 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 pharmaceutical organization with a GMP manufacturing environment. The site Engineering organization supports technical projects that ensure reliable, compliant, and efficient manufacturing operations. Role Description As a CQV Engineer, you support technical projects from commissioning through qualification and validation. You develop and execute test strategies, prepare CQV documentation, and provide technical guidance to project teams to ensure systems meet customer requirements and GMP standards. Key Responsibilities Develop and maintain CQV documentation, including validation plans, risk assessments, protocols, and reports Lead commissioning, qualification, and validation activities Develop test strategies and execute qualification testing Support project teams with CQV and GMP guidance Ensure technical solutions align with validation requirements and procedures Track project activities, issues, and timelines Report progress and escalate issues when required Requirements Minimum 3 years of CQV experience within pharmaceutical manufacturing Hands-on commissioning and qualification experience in secondary packaging operations Experience with print and inspection systems, such as Systech or Cognex Experience with Computerized Systems Validation (CSV) Strong knowledge of GMP validation practices Experience developing validation and qualification documentation Good technical writing skills in English Strong communication and stakeholder management skills Able to work independently with limited supervision Strong analytical and problem-solving skills

The Company A global pharmaceutical manufacturing organization focused on delivering high quality healthcare products through advanced production technologies and strict regulatory compliance. The company operates in a highly regulated environment and emphasizes innovation, quality, operational excellence, and patient safety. Role description The Validation Engineer supports engineering and validation projects within a GMP regulated manufacturing environment. This role focuses on commissioning, qualification, and validation activities for secondary packaging systems and computerized systems. The position requires strong technical expertise, documentation skills, and the ability to work independently while ensuring compliance with established quality standards and procedures. Responsibilities - Develop and maintain validation documentation including criticality assessments, qualification plans, validation plans, risk assessments, test protocols, traceability matrices, and summary reports - Lead commissioning, qualification, and validation activities for manufacturing systems - Execute testing activities and document results according to GMP requirements - Support project teams to ensure technical solutions comply with validation plans and internal procedures - Provide technical guidance throughout project execution - Ensure documentation is complete, accurate, and inspection ready - Support project delivery through design, implementation, testing, commissioning, and validation phases - Complete additional assignments and projects as requested by management Requirements - Minimum 3 years of commissioning, qualification, and validation experience within pharmaceutical manufacturing - Experience with secondary packaging systems - Experience with print and inspection systems such as Systech and Cognex Knowledge of computerized systems validation - Hands on commissioning and qualification experience within secondary packaging operations - Strong understanding of validation lifecycle documentation - Experience working in a GMP regulated environment - Excellent technical writing skills in English - Strong communication and stakeholder management abilities - Critical thinking and problem solving skills - Ability to work independently with limited supervision - Strong project coordination and prioritization capability Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me.