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4 resultaten voor Bedrijfseigenaar Es in Waals Brabant binnen een straal van 30 km
We hebben je zoekopdracht uitgebreid met 4 gelijkaardige vacatures.
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 * 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
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Jefferson Wells * Braine-l'Alleud * Contract duration unspecified * Full Time - Contracting – Brabant-Walloon - Your responsibilities * Monitor the progress of plans and projects, GQA performance, and compliance through * meaningful KPIs. This will boost operational efficiency and agility. Ensure and track appropriate * data entry performance of audit reports and CAPAs in the Veeva audit system. * Enable insights for the company through data collection, entry, and analysis in the audit * management tool (e.g., trending, KPIs, etc.). * Curate data, including quality checks of audit management tool as needed, for * KPIs/metrics on performance and information on trending. * Ensure maintenance and improvement of quality of critical data within the Quality * Management System (includes data entry of audit related information and data * monitoring).
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 . * Provide support during regulatory inspections, and quality improveme
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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 - Ensure adequate documentation processes and systems are available and followed for development projects (SOPs / Protocols / Report review…) * Be partner with other departments to identify, mitigate and subsequently resolve complianc
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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
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
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
Support the increase in laboratory capacity with a team of nearly 50 people, including analysts and specialists. Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * Cross-Functional Coordination: Work with (TL) to manage deviations, investigations, and priorities. Ensure smooth communication with different teams, especially during urgent situations. * Sample Management: Track samples using tools like LIMS, coordinate their reception, testing, and release, while ensuring compliance with client deadlines. * Deviations and Investigations: Manage deviations, root cause analyses, investigations, and changes related to processes. Precision in managing these tasks is crucial. * Documentation: Manage documentation related to validations, analyses, and regulatory authority r
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
Work collaboratively as part of a wider team and when required deputise for the of Bio MSAT Quality and other Bio MSAT Quality Leads * Process industrialization and Technical transfers within commercial manufacturing facilities * Build, establish and develop a governance model and process for Quality oversight of Internal and External MSAT for Bio Drug Substance and Drug Products which fosters continuous quality process improvement, optimized resource utilization and key indicator based performance monitoring * Promote quality best practices throughout the External & Clinical Supply Quality team and where possible business stakeholders. * Knowledge in multiple areas of Biopharma incl manufacturing and analytical testing, including the
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
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
SME Support: Provide technical expertise as needed in engineering and processes, especially in IT, data security, and automation. Jefferson Wells * Braine-l'Alleud * Contract duration unspecified * Full Time - Contracting – Walloon Brabant - Your responsibilities * Project Management: Coordinate a portfolio of projects (mainly in secondary packaging and medical devices), ensuring proper management of schedules and critical milestones. * Inter-project Coordination: Link technical teams, production, and experts (IT, automation) across different departments. * IT/Automation Project Oversight: Manage projects related to Data Integrity, IT security, and the automation of manufacturing facilities. Your profile * Project Management Skills (tools like MS Project). * Technical Knowledge in engineering, particularly in pharmaceutical production (secondary packa
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
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. * Using a Risk Based Approach, ensure that all Utilities, HVAC & Cleanroom Systems used by the campus and related supporting services are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and the company Corporate Policies & Procedures. * Support the to develop and implement technically robust and compliant Systems allowing to continuously improve their operations. * Responsible for all cGMP aspects related to the Utilities, HVAC & Cleanroom Systems owned by t
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
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
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Research Scientist in Histology and Image Analysis for Neurodegenerative Diseases
Research Scientist in Histology and Image Analysis for Neurodegenerative Diseases
Jefferson Wells
Braine-l'Alleud
Jefferson Wells * Braine-l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting - Brabant-Walloon - Vos responsabilités * Performing immunohistochemistry on brain sections, high-throughput image acquisitions using different microscopy instruments, and image analyses using advanced technologies such as artificial intelligence. * Regular interaction with and from different departments within the company, as well as with external organizations, to organize studies and ensure their completion. * Interpreting data and reporting results in an organized and timely manner. * Performing other duties as required and assigned. * Knowledge in neuroscience and neuroanatomy is preferred (rodent, monkey, or human brain). * Expertise in immunohistochemistry (fluorescent, colorimetric) and general knowledge in the field of histology with at least 2 years of experienc
Representing the non-clinical safety team in cross-functional meetings * Good knowledge about non-clinical safety evaluation of starting materials, synthesis intermediates and impurities, degradation products, leachables and extractables and associated guidelines. Jefferson Wells * Braine-l'Alleud * Contract duration unspecified * Full Time - Contracting – Walloon – Brabant - Your responsibilities * Writing and monitoring risk assessments for impurities (eg, justification of specifications, elemental impurities risk assessments, extractables and leachables, degradation products, ICH M7-compliant evaluations, etc.) * Planning, coordinating and monitoring the conduct of toxicology studies at contract research organizations in line with project timelines and budget * Performing and monitoring toxicological risk assessments for various he
Being one of the QA representatives for those activities and departments on the company site in case of alignment and level of quality related issues * Be one of the QA representatives in case of external audits regarding specific domain of knowledge (Master Data, purchasing, vendors management, warehouse, ... ) * In response to business requirements, identify, treat and communicate to QA and BTO management the possible issues of non-cGMP/21 CFR 820 compliance within Quality Management System and provide cGMP and QA expertise, interpretation and direction in order to create a framework of operational excellence enabling implementation of continuous improvement (e.g.: technical changes). * Train the company personnel regarding cGMP/21 CR 820 and Level of Quality requirements related to supply chain, purchasing, warehouse, operations, cold chain and SAP aspects.
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
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
Assurer la coordination de la validation des projets majeurs de TRD GMP en Drug Substance et Drug Product. * Assurer l'approche 'state of art' de la Validations du plan de validation (= stratégie de validation) jusqu'au Validation Summary Report, incluant : Ecriture, la revue et approbation de document de validation tels que les Risk Assessments, les protocoles IQ/OQ/PQ, les rapports IQ/OQ/PQ … * Expertise en validation IQ/OQ/PQ et GMP, solides connaissances en organisation matricielle et en gestion de projet. * Connaissance en validation de produit injectable. Jefferson Wells * RIXENSART * Contrat fixe à durée indéterminée * Plein temps - Consultance – Brabant Wallon - Vos responsabilités * Coordination de l'exécution des protocoles.