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10 resultaten voor QMS Manager in Diegem binnen een straal van 30 km
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Newpoint Professionals Quality & Food Safety System Manager Je bent een gepassioneerde en ervaren Manager Kwaliteit en Voedselveiligheid, met een scherpe blik voor detail. Back-up van Plant QFS Manager
We hebben je zoekopdracht uitgebreid met 9 gelijkaardige vacatures.
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Bonnes connaissances des systèmes qualité (QMS) : Déviations, Change Control, CAPA.
Bonnes connaissances des systèmes qualité (QMS) : Déviations, Change Control, CAPA.
Drive the implementation of the new Gene Therapy facility quality operational procedures into existing QMS (change control, deviation management, release procedures, training, etc).
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Clarify roles and responsibilities and interactions with other functions involved in QMS.
Ensuring continued compliance of the QMS to applicable regulations and guidelines, the company Corporate Policies & Procedures, objectives, plans and projects.
Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * The GMP oversight of different laboratories and production pilots, including packaging, and outsourcing * 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. * Provide support to build the end to end “issued copy process' for DEV/DSC entities. * Act as Reconciler by checking the correct completion of the “issued Copy” pro
Train company personnel regarding cGMP/GSP and QMS requirements related to manufacturing and analytical operations for clinical trials and stability studies.
Adviseren over en implementeren van aanpassingen in het bestaande Quality Management System (QMS).
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Ensure compliance of local Quality and Information Security Management Systems (QMS & ISMS) with international standards and regulatory frameworks (ISO 27001, ISO 9001, NIS/NIS2, NIST, etc.).
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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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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.
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
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
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
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
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
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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
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
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
Oversee Design & Development activities, from Inputs definition through Design Transfer (including Validation/Verification activities) Ensure risk assessments are performed at appropriate stages of development/commercialization and for decision making on issues arising. * Preparation and negotiation of Quality Agreements * Facilitate quality improvement activities at vendors and the company systems * Lead/review critical investigations * Work closely with in the Corporate QA teams (especially CM&C Clinical Supply QA, Corporate Compliance and Affiliate Quality Services) and key Technical Operations teams/Affiliate teams to ensure that all QA services for selected critical vendors are provided in an effective and efficient way * Work in accordance with HSE and Corporate
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
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
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
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