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7 resultaten voor Productie in Waals Brabant 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 * 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
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
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Jefferson Wells * Braine l'Alleud * Contract duration unspecified * Full Time - Contracting – Brabant-Walloon - Your responsibilities * Ensure the promotion of awareness of applicable regulatory and quality management system throughout the Braine Bio DS staff. * Support network initiatives related to quality and compliance for local implementation; act as connection for global initiatives related to quality and compliance for local implementation (including Regulatory Intelligence Network RIN). * Benchmark with external sources to understand industry trends and share with the department. * Serve as a quality and technical mentor/coach for interpretation and application of regulatory and global requirements for the Braine Bio DS staff. * Lead and model behaviors foundation to strong Quality Culture with connection to operations (e.g., build training materials based on
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 * 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.
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 - Brabant Wallon – Contracting - Vos responsabilités * 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. * Cooperate with a wide range of internal and external stakeholders, including contract manufacturing organizations, as part of a project team. * Design and execution of lab studies in relation to drug product development activities, capture and analyze data and author related documentation (write-ups, protocols, reports (eg filter selection and sizing, target fill volume assessment, compatibility assessments, clinical blinding, etc).
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Partner with QA and CMC Development/DCS colleagues to identify and mitigate Compliance risks, resolve potential regulatory observations. * 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. * Coordinate the development local instructions, liaise with key stakeholders in order to maintain common practices with regards to “issued copy” within development enti
Expertise in lab relocation is a plus - Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * Lead and coordinate the laboratory expansion and modernization project. * Manage commissioning and qualification activities for equipment and installations. * Collaborate closely with various internal departments and international . * Ensure compliance of facilities and processes with regulatory standards (GMP Pharma). * Identify technical needs and propose appropriate solutions. * Monitor project progress, manage risks, and maintain regular communication with . Votre profil * Bachelor degree with 5 years of relevant experience or Master's degree with 3 years of relevant experience; degree in science, engineering, or a related field. * Pharma skills (change request, deviation
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
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
As an Analytical Development – Document Specialist, your mission is to write and review scientific documents related to the stability and comparability of products in clinical development, primarily in phase 3. * Proficiency in analytical techniques (HPLC, UPLC, etc.). * Previous experience in stability or analytical validation (an asset). Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * Write stability and comparability protocols and reports. * Analyze and review scientific data to identify potential outliers. * Ensure data consistency and accuracy before submission to regulatory authorities. * Collaborate with and external . * Contribute to the continuous impro
Proven experience in data validation, preferably in a regulated environment. * Validate the integrity of transferred and transformed data in the new system. * Draft and execute validation protocols (tests, reports, documentation). * Collaborate with IT and business teams to guarantee data accuracy and consistency. * Manage a backlog of dashboards awaiting validation and ensure effective follow-up. * 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 * Define User Requirement Specifications (URS) and ensure compliance. * Communicate with various (IT, Business, QA, QC). * Be proactive in coordinating ta
Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * Execution of routine analytical experiments and method development activities under supervision. * Follow established procedures and protocols. * Collaborate with in routine tasks. * Seek guidance for troubleshooting and problem-solving. * Decision-making, primarily under supervision. * Follows standard protocols under supervision. Identifies issues with guidance. * Support and assist in project/operation planning, data analysis, and coordination. * Follows project/operational plans and guidelines. * Assists in project tasks under supervision. * Collaborates with and provides status updates. * Sample management (availability in lab, shipment and reception). * Day to day lab experiment/resources planning and equipment booking in GT
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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
Act as substitute for other Vendor Quality Leads in times of absenteeism (e.g. vacation, illness) * Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out for the assigned vendors * Ensure all Quality agreements are in place and take ownership of agreements for the vendors. Maintain Quality Agreement with the vendors up to date and perform periodic reviews and update of the agreement in close collaboration with the product GQLs and the vendors. * Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed and are reviewed within the requested time period. * Participate as QA representati
Oversee Design & Development activities, from Inputs definition through Design Transfer (including Validation/Verification activities) Ensure risk assessments are performed at appropriate stages of development/commercialization and for decision making on issues arising. * Preparation and negotiation of Quality Agreements * Facilitate quality improvement activities at vendors and the company systems * Lead/review critical investigations * Work closely with in the Corporate QA teams (especially CM&C Clinical Supply QA, Corporate Compliance and Affiliate Quality Services) and key Technical Operations teams/Affiliate teams to ensure that all QA services for selected critical vendors are provided in an effective and efficient way * Work in accordance with HSE and Corporate
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
Notre client est à la recherche d'un Project Manager Engineering Capex à consonnance technique pour driver un de leurs projets clefs. * Leader les achats (la négociation se faisant via le procurement manager), * Expérience avérée en gestion de projets CAPEX industriels, idéalement dans un environnement pharmaceutique, chimique ou biotechnologique. Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités - 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
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
Jefferson Wells * Braine-l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting - Brabant-Walloon - Vos responsabilités * Rédiger et mettre à jour les documents liés à la CCS * Organiser proactivement des réunions afin de collecter les informations auprès des * différents stakeholders (Production, Validation, Maintenance, Qualité, QC, MSAT…) * Développer un visuel afin de faire ressortir les éléments clés de la CCS (draft existant). * Ces documents doivent être finalisés pour l'inspection AFMPS de Juin. * Être en ordre de formation pour les activités dans le scope * Remonter tout problème significatif qui pourrait présenter un risque (qualité, coût, timing…). * Communiquer avec l'ensemble des pour assurer un mode de travail * coopératif. * Supporter les activités requises par le projet. Votre profil * Master * Bonnes connaissances des requis règlemen
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
As a Drug Product Expert, you will act as key enabler supporting the advancement of Pharma Science's Science & Technology and Innovation projects by leveraging own area of expertise to functional initiatives and contribute to PS transversal initiatives. * Senior expert in clinical DP development accountable for leading and running assigned project work packages, ranging from clinical formulation orientation work for FIH study up to commercial registration and launch for the development pipeline and as part of the life cycle management of commercial brands. * To ensure process robustness, validation and transfer of NCEs and Lifecycle management of mature product manufacturing process and technologies to commercial launch site. * To perform clinical formulation orientation work in collaboration with Non-Clinical Formula
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Virya Energy is looking for a Corporate controller to join its Finance Team and offers a unique opportunity to work in the field of renewable energy. As Corporate controller you will be involved in a broad range of controlling and financial planning related topics, both on group and entity level. Virya Energy Nv * Braine l'Alleud * Vast contract, onbepaalde tijd * Thuiswerken mogelijk - Jouw verantwoordelijkheden - Who are we? Combining the expertise and strength of key actors in the sustainable energy sector, Virya Energy's activities span the entire energy value chain from green energy generation to its distribution. Through its entities, Virya Energy is active and invests in the fields of wind and solar energy, sustainable hydrogen development, energy distribution and services for the energy industry. * Focused on short-term foreca
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Afin de renforcer son équipe Supply Chain, nous sommes à la recherche d'un Product Quality Specialist. * Brabant wallon * Vast contract, onbepaalde tijd * Voltijds - Votre nouvelle société - Notre client est une société internationale active dans le monde entier et spécialisée dans la gestion et la distribution de produits pétroliers et chimiques. Jouw verantwoordelijkheden - Votre nouveau rôle * Gérer la qualité des produits, analyser et déterminer les plans de mélange. * Maintenir la base de données des produits et participer aux audits des terminaux et des laboratoires. * Soutenir le dans l'investigation des plaintes relatives à la qualité des produits, la non-conformité des produits, la planification des audits client. * Soutenir la chaîne d'approvisionnement avec le calcul des recettes pour les mélanges en ligne. * Assurer le pro