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11 resultaten voor Wetenschap in Gilly binnen een straal van 30 km
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Jefferson Wells * Braine-l'Alleud * Contract duration unspecified * Full Time - Brabant Walloon – Contracting - Our partner is currently looking for a CMC Quality Solutions Specialist. Our partner is an international pharmaceutical company. Your responsibilities * Product Change Control Committee preparation and change controls follow-up * Maintenance and lifecycle management of QA product flows * Audits and Inspection anticipation and readiness * Product metrics * Review of Annual Stability Plan * SOPs and other control documents writing, review and approval as needed * Building and maintenance of Product QA knowledge (i.e., Product(s) SharePoint(s)) * Risk management and mitigation if applicable (e.g., follow-up on risk actions with QA stakeholders) * Review and approval of CMC sections linked to regulatory original submissions, renewals or variations during any mom
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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 - 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 - Contracting – Brabant Wallon - Vos responsabilités * Validate the integrity of transferred and transformed data in the new system. * Draft and execute validation protocols (tests, reports, documentation). * Define User Requirement Specifications (URS) and ensure compliance. * Collaborate with IT and business teams to guarantee data accuracy and consistency. * Manage a backlog of dashboards awaiting validation and ensure effective follow-up. * Communicate with various (IT, Business, QA, QC). * Be proactive in coordinating tasks and following up with . Votre profil * Bachelor's degree in Sciences * Proven experience in data validation, preferably in a regulated environment. * 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 - 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 . The person hired will work closely with a dynamic . * Coordinate the update of documentation according to the new defined structure. * Support Subject Matter Experts (SMEs) to ensure the timely delivery of documents. * Monitor and manage the documentation schedule. * Plan and organize the user training program (300+ people). * Ensure adherence to the schedule and follow up with in case of delays. * Coordinate the transition period between the old and new systems.
Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * Drive and promote a continuous quality and compliance mindset within Clinical Packaging & Logistics Operations, ensuring compliance with cGMP's and the company Quality Management System * Partner with Clinical Supply Compliance Team and management to quality initiatives that develop and maintain a high performing, scalable, and compliant quality system in CPLO. Ensure close interface with QA, CS Compliance and CPLO teams. * Coordinate and/or participate in the implementation of new regulatory standards within CPLO processes. * Represent the interests of the CPLO teams, serve in multidisciplinary Compliance project teams, working closely with other in a cooperative way to ensure project progression
Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités - Our client is looking for a Procurement Specialist, responsible for procurement operations at a biological production facility for raw materials. This role is crucial in ensuring a smooth supply chain transition from project phase to commercial production. * Manage procurement operations, ensuring timely ordering and delivery of materials. * Process purchase orders and monitor stock levels using SAP (MM module, client-side transactions). * Communicate with planning teams and to guarantee smooth supply chain operations. * Handle supplier negotiations related to delivery schedules and urgent needs. * Address quality investigations in coordination with and internal teams. * Serve as the main point of contact for operational procuremen
Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * Oversee Design & Development activities, from Inputs definition through Design Transfer (including Validation/Verification activities) * Review and approve relevant sections of the device design control documentation and/or Technical Documentation File as required * Review and approve protocols and reports for Verification & Validation studies, technology transfers, stability studies, etc… * Review and approve the company documentation. Ensure Design History File (DHF) is in place * Support Risk Management Activities related to devices. Ensure risk assessments are performed at appropriate stages of development/commercialization and for decision making on issues arising. * Ensure deliverables are issued in accordance with the D&D pl
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 * Contract duration unspecified * Full Time - Contracting – Brabant-Walloon - Your responsibilities * 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. * Execution of preliminary literature surveys leading to the definition of experimental programs. Planning, preparation and implementation of experimental and/or scale-up studies using standard and specialized equipment and techniques (laboratory, kilo-lab & pilot plant). Initiation, monitoring and work-up of reactions as well as isolation and purifications of materials (laboratory, kilo-lab and pilot scale). * Identification and definition of specific analytical tests in order to facilitate effective process development and ensure optim
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Master in ingenieurswetenschappen (of gelijkwaardig door ervaring) en meerdere jaren ervaring in industrieel productiebeheer.
We hebben je zoekopdracht uitgebreid met 2 vacatures buiten de geselecteerde regio
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Diploma: Je beschikt over een Master in de Industriële Wetenschappen - Elektromechanica.
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Delta Light * Belgium * Contract duration unspecified * Full Time - Delta Light HQ - Wevelgem - Möchten Sie Teil eines international tätigen Unternehmens mit fantastischen KollegInnen werden, in dem Ihre Ideen gehört und Ihre Talente gefördert werden? Klicken Sie hier, um sich direkt zu bewerben. Gesellschaft >Incorporated in Belgium in 1989 by business manager and designer Paul Ameloot, today Deltalight has developed to become the market leader and trendsetter in architectural lighting. Presenting innovative lighting designs, the company is recognised throughout the world for its subtle blend of ambiance, elegance, functionality, and design, both in interior and exterior lighting. The future of Deltalight is guaranteed with Peter and Jan Ameloot joining their father at the helm of the company, bringing additional dynamism and ambition to the team.
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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
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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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
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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