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6 resultaten voor SOP in Waals Brabant binnen een straal van 30 km
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Lead CPLO quality weekly meeting with management, SMEs and QA (Quality items review, SOP periodic reviews, training…).
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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
Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * Perform mapping of current situation of qualification/validation status in CMC Dev * Evaluate risk and define remediation plan with system owner * Complete and maintain tracker DT with prioritization * Project Management support for physical assets topics * Drive meetings to support Project * Update documents (sops, process, assessment, slides …) identified in project * Good knowledge qualification and validation process, IT compliance, GMP knowledge, data Integrity principles * Drive remediation plan, coordinate and finalize actions * Drive dashboard for for Dev entities * Interaction transversal entities (IT, Manufacturing, biological, chemical, QA, outsourcing Lead …) * On site assignment - Votre profil * Master/Bachelor: Biolog
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Supporting the training and development of - operators and team leaders (SOP, skills matrix, cross-training, leadership development) to increase accountability and involvement of each team member.
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
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Bruxelles * Vast contract, onbepaalde tijd * Voltijds - Introductie - Voor onze klant, een bedrijf dat behoort tot een gerenommeerde groep gespecialiseerd in infrastructuur, zijn we op zoek naar een Payroll & Benefits Specialist. Jouw verantwoordelijkheden - Als Payroll & Benefits Specialist beheer en optimaliseer je de verloning en de extralegale voordelen. Je zorgt voor een efficiënt beheer ervan in overeenstemming met de wettelijke verplichtingen. Daarnaast bied je strategische ondersteuning aan de directie en begeleid je de HR-teams. Je rapporteert rechtstreeks aan de Directie Human Resources. * Je bent verantwoordelijk voor de implementatie van een efficiënte strategie op het gebied van verloning en extralegale voordelen, met als doel te voldoen aan de kwaliteitsnormen van het bedrijf binnen de opgelegde deadlines en het vertrouwen van medewerkers en interne stak
We hebben je zoekopdracht uitgebreid met 1 vacatures buiten de geselecteerde regio
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Hologic * Belgium * Vast contract, onbepaalde tijd * Voltijds - We are seeking a visionary and dynamic Director of Technical Support to join our team at our Zaventem site. In this critical leadership role you will oversee our customer technical support operations, drive strategic initiatives, and ensure exceptional service delivery to our clients. You will be responsible for leading a team of , managing solution-oriented projects, and fostering a culture of excellence and continuous improvement. Jouw verantwoordelijkheden * Lead and manage the central service operations ensuring high standards of service delivery and client satisfaction. * Develop and implement a customer service strategy aligning with Hologic's overall business objectives. * Oversee the performance and development, providing guidance, training, and professional development opportunities.
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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
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
Minimum 3-5 years of experience in Quality Assurance in a regulated pharmaceutical environment or other life science or health-related field. * Experience in manufacturing batch record QA review and deviation QA review is a must. 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 * Experience in pharma is a must (must quickly become autonomous): experience with chemical/pharmaceutical production, development, and/or regulatory requirements, inclu
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
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
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
Suivi des KPI HSE * Min 3 ans d'expérience en matière de suivi de chantiers en tant que membre du département HSE (conseiller en prévention niveau 2) ou en tant que responsable de chantier. Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * Réaliser le suivi de chantiers sur le terrain (construction, rénovation, revamping, démolition, aménagement de nouveaux bâtiments et/ou bâtiments existants sur le site de Braine l'Alleud) * Réaliser des analyses de risques préalables (JRA) aux différentes phases de chantier * Réaliser les analyses d'incident et d'accident liés aux activités supervisées * Relire et superviser les PPSS & PGSS de chantier * Rédiger les rapports suite aux visites de chantier * Tisser les contacts nécessaires avec les personnes-resso
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For our client, Robert Half is looking for a Group Reporting & System Manager (m/f/x). As a key player in an international chemical group, the Group Reporting & System Manager will be responsible for optimizing reporting processes, automating data flows, and harmonizing reporting standards across subsidiaries. Our client is an international chemical group located in Ottignies. * Optimize financial reporting processes and drive automation initiatives. * Lead the transition from Excel-based reporting to SAP-based solutions. * Harmonize reporting and financial processes across global subsidiaries. * Act as the interface between Finance and IT to ensure s
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
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
Ensure the promotion of awareness of applicable regulatory and quality management system throughout the Braine Bio DS staff. * Develop appropriate tools to collect quality-related risks and ensure escalation as per companies quality management system. * Make connection within companies organization to improve visibility and influence of the team (e.g., quality systems & strategy, internal manufacturing quality, global quality auditing). * Demonstrated experience in quality system / quality compliance. Jefferson Wells * Braine l'Alleud * Contract duration unspecified * Full Time - Contracting – Brabant-Walloon - Your responsibilities * Support network initiatives related to quality and compliance for local implementation; act as connection for global initiatives related to quality and compliance for lo
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Senior Business Developer - Sustainable Energy Solutions
Senior Business Developer - Sustainable Energy Solutions
Eoly Energy
Braine l'Alleud
Thuiswerken mogelijk
To lead this initiative, we are looking for a dynamic Senior Business Developer to lead business development activities, strengthen market leadership and establish strategic partnerships. As part of our renewables business, C&I Solutions specializes in helping commercial and industrial clients transition to sustainable energy through customized, scalable solutions. Our team works with businesses to implement comprehensive renewable energy systems - from solar installations and wind turbines to EV charging infrastructure - while ensuring minimal disruption to their operations and maximum return on investment. Your role will be crucial in understanding each client's unique needs and growth trajectory, creating flexible energy solutions that evolve with their business while maximizing ef
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
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
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As a Talent Manager, you will play a critical role in developing, engaging and retaining our Talent within our organisation, in partnering with stakeholders. You hold a Master's degree and bring around 10 years of experience in SOFT HR, specifically in L&D and Talent Management. You will also be involved in several HR-processes and projects in order to support our international growth. * Collaborate with and to support internal career growth opportunities by developing and implementing programs and initiatives that promote talent mobility. * Coordinate our Talent Review process with focus on potential, succession and retention. Your expertise and passion for talent development make you the ideal candidate for this expert-level role. *
Virya Energy is looking for a Corporate controller to join its Finance Team and offers a unique opportunity to work in the field of renewable energy. As Corporate controller you will be involved in a broad range of controlling and financial planning related topics, both on group and entity level. Virya Energy Nv * Braine l'Alleud * Vast contract, onbepaalde tijd * Thuiswerken mogelijk - Jouw verantwoordelijkheden - Who are we? Combining the expertise and strength of key actors in the sustainable energy sector, Virya Energy's activities span the entire energy value chain from green energy generation to its distribution. Through its entities, Virya Energy is active and invests in the fields of wind and solar energy, sustainable hydrogen development, energy distribution and services for the energy industry. * Focused on short-term foreca
Au sein de la BU WIND and SOLAR Europe d'un Groupe producteur d'énergies renouvelables, sous la responsabilité de « Belgique » vous occuperez le poste de Business Developer Wind Belgique (H/F). Cela signifie qu'Eoly Energy est responsable du développement, de la construction et de l'exploitation de tous les projets d'énergie éolienne terrestre en Belgique pour le compte de Virya Energy. Elle a été fondée en 2013 et fait partie de Virya Energy, une entreprise énergétique belge qui se concentre sur les énergies renouvelables. * Développer les projets éoliens depuis la validation du business plan jusqu'au stade « Ready To Build », en vous appuyant sur l'équipe des ingénieurs d'étude et sur l'équipe de Project Management - Ces dernières années, Eoly Energ
In a context of strong business growth, the Prospector Wind Flanders will reinforce the prospecting team of Virya's Energy Portfolio of wind projects in Flanders, both in agricultural and business zones. Eoly Energy * Braine l'Alleud * Vast contract, onbepaalde tijd * Thuiswerken mogelijk - Jouw verantwoordelijkheden - Company profile - As part of Virya Energy's integrated approach to sustainable energy, our Grid Solutions division—formerly known as Eoly Energy—specializes in developing utility-scale renewable energy projects across multiple markets. We focus on wind farms and solar installations that feed into the energy grid, complementing the commercial and industrial solutions handled by our C&I business line. At Grid Solutions, we develop renewable energy projects from initial concept through construction and into operations.