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6 resultaten voor CMC in Waals Brabant binnen een straal van 30 km
Perform mapping of current situation of qualification/validation status in CMC Dev
Provide support in the completion of the relevant sections of the CMC regulatory submissions and regulatory briefing documents and response to questions from authorities.
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Work transversally across projects and groups in line with the needs of the business and as part of the Drug Substance Process Sciences organization and wider CMC
Providing support in the construction of CMC regulatory documents and positional papers (i.e., IND/NDA documents, MAA, etc.)
Partner with QA and CMC Development/DCS colleagues to identify and mitigate Compliance risks, resolve potential regulatory observations.
Partner with QA and CMC Development/CTS colleagues to identify and mitigate Compliance risks, resolve potential regulatory observations.
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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
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
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
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 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
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.
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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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
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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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
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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.
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.
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
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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
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
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