Reistijd
... Min.
Sollicitatie methode
Taal van de job
Vaardigheden
Functiecategorie
Sector
Regio
Gemeente
Ervaringsniveau
Type contract
Voltijds/deeltijds
Voltijds
12
12 resultaten voor Protocols in Waals Brabant binnen een straal van 30 km
){kind=logo}
Ensure adequate documentation processes and systems are available and followed for development projects (SOPs / Protocols / Report review…)
Review and approve protocols and reports for Verification & Validation studies, technology transfers, stability studies, etc…
){kind=logo}
Assist the in implementing safety protocols
Draft and execute validation protocols (tests, reports, documentation).
Autonomously write high quality source documents including experiment plans, protocols and reports according to data integrity requirements to enable regulatory filing. Support department with the review of protocols and reports from other SMEs. * Excellent communication and presentation skills with the ability to convey information in a clear and concise manner to write clear instructions, protocol and reports
Write stability and comparability protocols and reports.
){kind=logo}
Authoring and/or reviewing reports, protocols, guidelines, guidances and SOPs and ensuring harmonized approaches with regard to the toxicological assessments
Design and execution of lab studies in relation to drug product development activities, capture and analyze data and author related documentation (write-ups, protocols, reports (eg filter selection and sizing, target fill volume assessment, compatibility assessments, clinical blinding, etc).
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 * RIXENSART * Contrat fixe à durée indéterminée * Plein temps - Consultance – Brabant Wallon - Vos responsabilités * 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 … * Coordination de l'exécution des protocoles. Votre profil * Medior profil minimum avec au moins 5 ans d'expérience. * Expertise en validation IQ/OQ/PQ et GMP, solides connaissances en organisation matricielle et en gestion de projet. Solides compétences en communication, organisation et influence pour travailler de manière transversale.
Challenge, review and approve qualification and validation (IQ,OQ, PQ, equivalence certificate, requalification protocol/report) documentation and ensure they are written in accordance with the companies Vaccines standards and procedures
ISS Facility Services * BRAINE-L'ALLEUD * Contrat fixe à durée indéterminée * Plein temps * organise, coordonne et supervise les activités planifiées pour les banquets, réceptions, ou autres événements * planifie les activités du personnel de service, assure la répartition des tâches, donne des directives concernant le service, le menu, les boissons, etc. * veille éventuellement à avoir plus de personnel de service en accord avec le du personnel, s'occupe de l'accompagnement et de la formation des collaborateurs * contrôle la mise en place de la salle, des tables, du matériel de cuisine, des choses nécessaires, etc.; signale les défectuosités * prend part aux activités de service; assure le suivi du protocole de service et des règles internes; garantit un service qualitatif et aimable des clients
Deze jobs kunnen interessant zijn voor jou
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
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 * 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
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
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
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
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
){kind=logo}
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.
){kind=logo}
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
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
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 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. * 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 * Consult and guide the teams in establishment of controls to mitigate compliance risk; * Assist management in the coordination/management of training plans & matrix and ensure