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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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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.
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
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 – Walloon Brabant - Vos responsabilités * Participate to the development of new products and processes * Give directions from early development up to lifecycle management, from particle design up to final product * Work autonomous, well-organized and use your pro-active thinking skills * Be self-reflective on the gathered data * Use your creativity to develop new analytical methods or even develop new technology * Drive team spirit and encourage collaboration * Being a leader in powder characterization by leveraging Materials Science to drive overall Product Development in order to obtain the right drug for every patient * Guide the Product Development by connecting powder /particle insights with manufacturing technologies and overall product performance
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
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
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
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
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
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
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.
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
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
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
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. We will be your career partner for each step along the way. Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * 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 consolid
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
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
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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Afin de rejoindre le département de Chimie de notre laboratoire de SGS Lab Simon à Wavre, nous sommes actuellement à la recherche d'un(e) « analyste en CHEMISTRY - PHYSICS » * Formation de niveau A1 (bachelier) en chimie analytique * Enregistre promptement, précisément et intégralement les données nécessaires à la traçabilité des opérations effectuées conformément aux procédures en vigueur (échantillons, réactifs, appareillages, initiales, dates) ; * Signale immédiatement tout résultat hors spécification au Team Leader conformément à la procédure en vigueur ; * Signale au plus vite au Team Leader tout besoin en matériel et réactifs ; * Respecte les procédures mises en vigueur, signale les écarts au Team Leader ; * Exp
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
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
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In Europe, our Connected and Sharing Solutions Division is currently looking for a Business Developer Automotive to strengthen this team. * Generate lead and create new business model for SW and content * Ideally 1 proven track record in business development of digital/high-tech products * Master's degree in Business, Marketing, Innovation or Engineering - Aisin * Braine-l'Alleud * Contract duration unspecified * Full Time - AISIN EUROPE is part of the Japanese AISIN Corporation, a leading supplier of automotive technology products employing more than 100,000 people worldwide. AISIN, one of the largest automotive Tiers1 supplier, is a global mobility company with the mission to deliver beauty to our future earth, bringing freedom and happiness to 'movement'. In Europe, our Connected and Sharing Soluti