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16 resultaten voor Kwaliteitsborging in Zinnik binnen een straal van 30 km
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Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * Promote Quality and Operational Excellence and cultivate “Quality Culture”, “Compliance Awareness”, “Continuous Improvement Attitude” & “Accountability Culture” across the UCB teams. * Drive Quality Leadership on Quality & Compliance Strategy and interact with other functional areas to effectively communicate system & process requirements. * Maintaining and continuously improving the Quality Management System and related processes. * Ensuring continued compliance of the QMS to applicable regulations and guidelines, the company Corporate Policies & Procedures, objectives, plans and projects. * Using a Risk Based Approach, ensure that all Utilities, HVAC & Cleanroom Systems used by the campus and related supporting services are compl
Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * S'assurer du respect cGMP. * Participer activement à la préparation des lots de process performance qualification (PPQ). * Revoir et approuver les dossiers de lot de production en version papier et électronique. * Participer à la gestion/revue/approbation des déviations. * Participer à la gestion/revue/approbation des CAPA. * Participer à la gestion/revue/approbation des change controls. * Revoir et approuver les protocoles et rapports de validation (CIP/SIP/EM/Thermal mapping). * S'assurer que les risques/non conformités identifiées sont traités de manières adéquates et remontés dans les temps. Votre profil * Diplômé(e) de l'enseignement supérieur de type Bachelier ou Master (biotechnologie, pharmacie, etc.). * Bilingue Français e
Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * S'assurer du respect cGMP. * Participer à la gestion/revue/approbation des déviations. * Participer à la gestion/revue/approbation des CAPA. * Participer à la gestion/revue/approbation des change controls * Participer activement à la préparation des lots de process performance qualification (PPQ). * S'assurer que les risques/non conformités identifiées sont traités de manières adéquates et remontés dans les temps. Votre profil * Diplômé(e) de l'enseignement supérieur de type Bachelier ou Master (biotechnologie, pharmacie, etc.). * Expérience dans un environnement GMP. * Bonnes connaissances des systèmes qualité (QMS) : Déviations, Change Control, CAPA. * Bilingue en Français et Anglais. Notre offre
Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités - You will ensure the follow-up of productions; this involves monitoring chemical synthesis operations through dossier review, managing deviations, and following change control (review of change control). Daily contact with production is required. Votre profil * Bachelor's degree in Sciences * Minimum 3-5 years of experience in Quality Assurance in a regulated pharmaceutical environment or other life science or health-related field. * Experience in pharma is a must (must quickly become autonomous): experience with chemical/pharmaceutical production, development, and/or regulatory requirements, including knowledge of production best practices in the pharmaceutical industry.
Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * The GMP oversight of different laboratories and production pilots, including packaging, and outsourcing * The GSP oversight (non- GMP activities) of different development entities, located on the Braine site (BE), the Slough site (UK) and the Monheim site (DE). * Drive continuous quality improvement process, ensuring that the Quality Management System in support of product development and clinical supplies, work in a way that ensure product quality, safety and efficacy, meet regulatory requirements and expectations and operate in a fit for purpose and in a smarter way. * Provide support to build the end to end “issued copy process' for DEV/DSC entities. * Act as Reconciler by checking the correct completion of the “issued Copy” pro
Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités - As a Gene Therapy Quality Partner, you will support the Genesis project GMP Readiness program to timely obtain health authorities authorization to manufacture Gene Therapy clinical batches in the new facility pilot plant. * Drive the implementation of the new Gene Therapy facility quality operational procedures into existing QMS (change control, deviation management, release procedures, training, etc). * Support the documented assessment of the GMP & Operations Readiness program progresses according to project key milestones. * Support management of materials & product specifications, execute incoming materials release * Support the consolidation and writing of the Contamination Control Strategy * Drive the 's qualification program
Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * Validate the integrity of transferred and transformed data in the new system. * Draft and execute validation protocols (tests, reports, documentation). * Define User Requirement Specifications (URS) and ensure compliance. * Collaborate with IT and business teams to guarantee data accuracy and consistency. * Manage a backlog of dashboards awaiting validation and ensure effective follow-up. * Communicate with various (IT, Business, QA, QC). * Be proactive in coordinating tasks and following up with . Votre profil * Bachelor's degree in Sciences * Proven experience in data validation, preferably in a regulated environment. * Strong proficiency in SQL for executing tests and validating data.
Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * Drive and promote a continuous quality and compliance mindset within Clinical Packaging & Logistics Operations, ensuring compliance with cGMP's and the company Quality Management System * Partner with Clinical Supply Compliance Team and management to quality initiatives that develop and maintain a high performing, scalable, and compliant quality system in CPLO. Ensure close interface with QA, CS Compliance and CPLO teams. * Coordinate and/or participate in the implementation of new regulatory standards within CPLO processes. * Represent the interests of the CPLO teams, serve in multidisciplinary Compliance project teams, working closely with other in a cooperative way to ensure project progression
Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * Oversee Design & Development activities, from Inputs definition through Design Transfer (including Validation/Verification activities) * Review and approve relevant sections of the device design control documentation and/or Technical Documentation File as required * Review and approve protocols and reports for Verification & Validation studies, technology transfers, stability studies, etc… * Review and approve the company documentation. Ensure Design History File (DHF) is in place * Support Risk Management Activities related to devices. Ensure risk assessments are performed at appropriate stages of development/commercialization and for decision making on issues arising. * Ensure deliverables are issued in accordance with the D&D pl
Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * Work closely with Clinical Manufacturing Teams to ensure that the Quality Management System in support of product development and clinical supplies, work in a way that ensure product quality, safety and efficacy, meet regulatory requirements and expectations and operate in a fit for purpose and in a smarter way. * More specifically, provide quality support for qualification and validation activities related to Clinical Manufacturing activities like facilities cleaning processes, viable and non-viable environmental monitoring, equipment and system qualification/validation * Drive the continuous QA improvement process. Ensure adequate documentation processes and systems are available and followed for development projects (SOPs / Prot
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Barry Callebaut * Halle * Contract duration unspecified * Full Time - Introduction - At Barry Callebaut, we are on a journey to transform the cocoa and chocolate industry. As the world's leading manufacturer of high-quality chocolate and cocoa products, our actions truly shape the future of our industry. We are a business-to-business company, serving the entire food sector, from the cocoa bean to the finest chocolate product. We are a company with a purpose, we believe in doing well by doing good and reinvesting in the communities we operate. We have a long-standing commitment to sustainability and our goal is to shape a sustainable cocoa and chocolate future. We are headquartered in Zurich, and have more than 12,000 passionate Employees working in more than 40 countries worldwide. We are very proud of who we are and what we do.
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Jefferson Wells * Braine-l'Alleud * Contract duration unspecified * Full Time - Brabant Walloon – contracting - Our partner is looking for a Qualification & Validation Engineer to join its team. This international company is well-known for its pharmaceuticals. These positions aim to ensure the qualification and validation of production equipment, primarily for solid dosage forms and packaging. Your responsibilities * Qualification and validation of production equipment and installations * Cleaning validation within the scope of technology transfers and pharmaceutical development * Participation in process qualification optimization and continuous improvement * Support for various expansion and production capacity optimization projects * Interaction with production, maintenance, and quality assurance teams - Your profile
Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités - Notre client est à la recherche d'un Project Manager Engineering Capex à consonnance technique pour driver un de leurs projets clefs. Le projet concerne la distribution centralisée de solvant dans le bâtiment upstream. Il souhaite retirer les fûts de solvant de la zone de production et centraliser leur alimentation via des cuves tampons, et de manière automatisée. * Comprendre et driver les aspects techniques de ce projet (et leader une équipe composée de chimistes, process engineers, automation engineer, electrical engineer, EHS, QA technique…) * Mettre à jour le budget et le forecast du projet * Suivre et leader le planning du projet * Leader les achats (la négociation se faisant via le procurement manager),
Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * Perform mapping of current situation of qualification/validation status in CMC Dev * Evaluate risk and define remediation plan with system owner * Complete and maintain tracker DT with prioritization * Project Management support for physical assets topics * Drive meetings to support Project * Update documents (sops, process, assessment, slides …) identified in project * Good knowledge qualification and validation process, IT compliance, GMP knowledge, data Integrity principles * Drive remediation plan, coordinate and finalize actions * Drive dashboard for for Dev entities * Interaction transversal entities (IT, Manufacturing, biological, chemical, QA, outsourcing Lead …) * On site assignment - Votre profil * Master/Bachelor: Biolog
Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * Establish and build a network with the company key stakeholders in relation to Internal and External MSAT for Bio Drug Substances and Drug Products. * Troubleshooting and ensure issues are resolved in accordance with policies and procedures * Process improvement and life cycle management strategy within regulatory file boundaries * Process industrialization and Technical transfers within commercial manufacturing facilities * Complex investigations and CAPA plans implementation * Process validation oversight and continuous process verification (CPV) * Analytical method transfer and troubleshooting support. * Build, establish and develop a governance model and process for Quality oversight of Internal and External MSAT for Bio Drug S
Jefferson Wells * Braine-l'Alleud * Contract duration unspecified * Full Time - Contracting – Walloon Brabant - Your responsibilities * The GMP oversight of different laboratories and production pilots, including packaging, and outsourcing * The GSP oversight (non- GMP activities) of different development entities, located on the Braine site (BE), the Slough site (UK) and the Monheim site (DE). * Drive continuous quality improvement process, ensuring that the Quality Management System in support of product development and clinical supplies, work in a way that ensure product quality, safety and efficacy, meet regulatory requirements and expectations and operate in a fit for purpose and in a smarter way. * Provide support for qualification and validation activities of the different laboratories and production pilots.
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Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * Département In vivo Pharmacologie - spécialisé dans les études in vivo, études de comportements sur différents rongeurs principalement souris et rats * Collectes de tissus, administration de composés et check effet sur le comportement des animaux * Préparation des réactifs et gestion du laboratoire - Votre profil * Master ou Doctorat en Sciences ou équivalent * Au moins un an d'expérience In vivo (meurins) * Titulaire du Felasa B * Connaissances en Excel * Excellentes compétences en Anglais - Notre offre - Jefferson Wells vous propose un contrat permanent en tant que consultant avec un package salarial attractif et vous donnera accès à des formations sur des sujets techniques ainsi que sur les soft skills. Nous serons votre partena
Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * S'assurer que les requis GMP soient intégrés dans le design des équipements / systèmes. * Participer au processus de sélection des vendeurs. * Assurer un oversight qualité tout le long de la phase de construction / installation / mise en service. * Développer les procédures permettant leur utilisation et leur maintenance. * Assurer le release avant utilisation GMP. * S'assurer du respect du timing et de la qualité et aider au respect des budgets. * S'assurer que les procédures sont à jour. * S'assurer que la stratégie de training soit définie. * S'assurer de la correcte implémentation tout au long du projet * Définir le scope et les membres (core team et ad-hoc team). * Leader les discussions du groupe de travail pour dérouler le p
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We are looking for a Project Manager to support the development of our hydrogen production projects in Flanders and Wallonia. As part of Virya Energy's hydrogen activities, you'll join a specialized team developing a growing portfolio of hydrogen production plants across Belgium and the Netherlands, with ambitions to expand further. We combine production development with innovative infrastructure solutions through DATS 24's refuelling network, while actively shaping the hydrogen market by establishing strategic partnerships with off takers. This unique position allows us to drive the entire hydrogen value chain forward, from production to end-user applications. * Lead and coordinate projects from concept to completion. * Monitor
Ability to participate to process development as scientist in specific area of expertise as process characterization, optimization, understanding, industrialization and investigation QbD development of the different compounds in development. * Development of an in-depth understanding of the process chemistry and process engineering relating to the postholder's projects and an awareness of chemical aspects of other projects within the group. * Identification and definition of specific analytical tests in order to facilitate effective process development and ensure optimum product quality. * Participation in the transfer of chemical processes from laboratory to kilo-lab, pilot plant and/or production, under the direction of Science lead. * Knowledge in
Translating these market requirements into clear supply chain processes. * Managing distribution processes, designing solutions that meet business and IT needs. * Minimum of 5 years of experience in Supply Chain, ideally with expertise in distribution networks, supply chain management, and customer service management. * Experience in Supply Chain Planning or Logistics role within pharma or food industry. * Ensuring smooth communication between business teams and IT departments, especially for market-specific solutions. * Leading Request for Proposals (RFP) processes with external and writing user stories when necessary. Jefferson Wells * Braine l'Alle
As an innovative leader, we are looking for an experienced O&M Engineer to join our team and play a key role in optimizing our hydrogen operational services. As part of Virya Energy's hydrogen activities, you'll join a specialized team developing a growing portfolio of hydrogen production plants across Belgium and the Netherlands, with ambitions to expand further. We combine production development with innovative infrastructure solutions through DATS 24's refuelling network, while actively shaping the hydrogen market by establishing strategic partnerships with off takers. This unique position allows us to drive the entire hydrogen value chain forward, from production to end-user applications. * Oversee daily operations of our installations (including 24 wind turbines) via a monitoring system, ensuring
Ensure the promotion of awareness of applicable regulatory and quality management system throughout the Braine Bio DS staff. * Develop appropriate tools to collect quality-related risks and ensure escalation as per companies quality management system. * Make connection within companies organization to improve visibility and influence of the team (e.g., quality systems & strategy, internal manufacturing quality, global quality auditing). * Demonstrated experience in quality system / quality compliance. Jefferson Wells * Braine l'Alleud * Contract duration unspecified * Full Time - Contracting – Brabant-Walloon - Your responsibilities * Support network initiatives related to quality and compliance for local implementation; act as connection for global initiatives related to quality and compliance for lo
Our client is looking for a Documentation & Training Coordinator for a major project aimed at modernizing the artwork management system. This role is crucial to ensure the update and finalization of associated documentation, as well as the coordination of training for . * Coordinate the update of documentation according to the new defined structure. * Monitor and manage the documentation schedule. * Experience in documentation coordination for large projects. Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités - The person hired will work closely with a dynamic . * Support Subject Matter Experts (SMEs) to ensure the timely delivery of documents. * Plan and organize the user training p
Technical expert in the establishment of robust, fit for purpose injectable drug product manufacturing processes from toxicology studies or first in human until BLA approval. * Define and select drug product manufacturing processes and parameters for clinical manufacture. * Design DP processes for sterile injectable drug products in liquid or lyophilized powder form, in vials, pre-filled syringes or as combination products). * Define the investigational medicine product preparation process in clinical trials. * Provide support to process performance qualification/validation Ensure products are manufactured in accordance with the company quality system, cGMP and latest regulatory requi