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1 resultaat voor CTS in Waals Brabant binnen een straal van 30 km
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Partner with QA and CMC Development/CTS colleagues to identify and mitigate Compliance risks, resolve potential regulatory observations.
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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
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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
We will be your career partner for each step along the way. 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
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
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.
Être un support HSE pour l'Engineering dans les gaps assessment Safety by design des activités à haut risques * Apporter un soutien à l'Engineering pour assurer un environnement optimal de santé et de sécurité et Bien-être pour les employés, la sécurité des équipements et des processus allant au-delà de la conformité (directives et exigences HSE et exigences légales). * Être un soutien solide au-delà d'un conseiller, dans la conduite d'une culture HSE positive et orientée vers l'action - Jefferson Wells * Braine-l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting - Brabant Wallon - Vos responsabilités * Collaborer au déploiement et à la consolidation opérationnelle des activités à hauts risques * Être possiblement un support au service interne de sécurité (SIPP) dans ses missions légales (analyses
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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
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
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
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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Active member of Lab Quality meetings: act as strong and project. * Be responsible for metrology aspect: Ensure mapping and reports delivered by the External vendors are compliant with the specificities defined by the Lab. * Assures accurate collection and processing of biological specimens to assure quality of analytical data. * Integrate and monitor quality indicators (key performance indicator = KPI), handle non-conformities and claims as well as corrective and preventive actions. Jefferson Wells * Brussels * Contract duration unspecified * Full Time - Brussels – contracting - Your responsibilities * Lead Equipment management process * Be the SME on that process for the entire unit * Train the from equipment purchase to equipment installed. * Ensure at least 1 internal Audit/year.
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
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 * 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
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
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
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
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Als Project Engineer Pipelines (M/V/X) kom je terecht binnen het team Pipelines, Rotating Equipment & Coating, dat deel uitmaakt van onze Business Unit Energy & Process Industries (EPI). Als Project Engineer Pipelines (M/V/X) ben je verantwoordelijk voor het inspecteren en controleren van materialen en drukapparatuur bij verschillende Belgische en buitenlandse fabrikanten. Binnen het team Pipelines, Rotating Equipment & Coating voeren we onder andere controles en inspecties uit op installaties voor het transport en de opslag van gevaarlijke producten (pijpleidingen en bijhorende installaties). Vinçotte * Belgie- Buitenland * Vast contract, onbepaalde tijd * Voltijds - Introductie - Binnen EPI richten we ons op klanten in de energie en
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