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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
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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.
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Colruyt NV (Colruyt Group) * HALLE * Vast contract, onbepaalde tijd * Thuiswerken mogelijk - Introductie - Over Colruyt Group - Meer dan 33.000 mensen die samen dingen in beweging zetten. Als grote, duurzame Belgische retailer willen we écht iets betekenen voor onze medewerkers, klanten en partners. Reken maar dat we trots zijn op wat we vandaag doen! We zoeken voortdurend naar opportuniteiten en duurzame samenwerkingen. Altijd toekomstgericht en vanuit de behoefte van de klant. Doede mee? Colruyt Group, dat is een op en top Belgische retailer met meer dan 40 winkelformules en webshops. Met een efficiënte supply chain, eigen productiesites en uitgebreide ondersteunende diensten zoals IT, Data & Analytics, Call Center, HR en Marketing, behoren we tot de grootste private werkgevers van het land. Elk merk en bedrijf binnen Colruyt Group heeft een eigen identiteit, met de
Provide guidance and expert advice to development scientists, particularly with regard to the appropriate interpretation of national and international GMP regulations and guidelines
Orelia Ter Beuken BV * ALSEMBERG * Vast contract, onbepaalde tijd * Voltijds - Introductie - De medewerkers van Orelia zijn de drijvende kracht achter onze organisatie. Zij weten dat onze bewoners dagen met een gouden randje verdienen in de laatste jaren van hun leven. Om hen de beste zorg te kunnen bieden, hebben we versterking nodig. Kom jij ook bij ons schitteren? Jouw verantwoordelijkheden - Als logopedist ben je vanuit je specifieke deskundigheid mede verantwoordelijk voor de ontwikkeling en optimalisering van de communicatieve vaardigheden en vaardigheden met betrekking tot eten en drinken. Je volgt bewoners op met specifieke communicatieproblemen, zoals afasie, dysartrie, … en ondersteunt hen met communicatietraining in het kader van hun medische behandeling. Ook bewoners met slikproblemen begeleid je en je evalueert de maaltijden op basis van medische antecede
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Manpower * Manage * Contrat fixe à durée indéterminée * Plein temps - Manpower recherche, pour le compte de son client, un ou une « Calculateur » passionné(e) par le domaine technique et désireux de contribuer au succès d'une entreprise reconnue pour son expertise et son innovation. Vos responsabilités - Analyser des demandes d'offres, des cahiers des charges et des plans associés pour proposer des solutions de maintenance adaptées. Élaborer des budgets précis et compétitifs en adéquation avec les besoins des clients. Collaborer étroitement avec les pour rédiger les contrats de maintenance. Effectuer des visites de sites pour identifier les équipements techniques. Participer aux discussions avec les internes et aux réunions de lancement de projet, aussi bien en interne qu'avec les clients. Respecter et promouvoir les consignes de sécurité et signaler toute anomalie ou
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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
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
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
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
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
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
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
Partner with QA and CMC Development/CTS colleagues to identify and mitigate Compliance risks, resolve potential regulatory observations. We will be your career partner for each step along the way. Jefferson Wells * Braine-l'Alleud * Contract duration unspecified * Full Time - Contracting – Walloon Brabant - Your responsibilities * 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 expec
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
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
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
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.
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
Representing the non-clinical safety team in cross-functional meetings * Good knowledge about non-clinical safety evaluation of starting materials, synthesis intermediates and impurities, degradation products, leachables and extractables and associated guidelines. Jefferson Wells * Braine-l'Alleud * Contract duration unspecified * Full Time - Contracting – Walloon – Brabant - Your responsibilities * Writing and monitoring risk assessments for impurities (eg, justification of specifications, elemental impurities risk assessments, extractables and leachables, degradation products, ICH M7-compliant evaluations, etc.) * Planning, coordinating and monitoring the conduct of toxicology studies at contract research organizations in line with project timelines and budget * Performing and monitoring toxicological risk assessments for various he
As a Drug Product Expert, you will act as key enabler supporting the advancement of Pharma Science's Science & Technology and Innovation projects by leveraging own area of expertise to functional initiatives and contribute to PS transversal initiatives. * Senior expert in clinical DP development accountable for leading and running assigned project work packages, ranging from clinical formulation orientation work for FIH study up to commercial registration and launch for the development pipeline and as part of the life cycle management of commercial brands. * To ensure process robustness, validation and transfer of NCEs and Lifecycle management of mature product manufacturing process and technologies to commercial launch site. * To perform clinical formulation orientation work in collaboration with Non-Clinical Formula
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Nous sommes actuellement à la recherche d'un(e) Analyste en Chimie pour rejoindre nos laboratoires SGS Lab Simon et SGS LCA. SGS Group Belgium * Wavre * Contrat fixe à durée indéterminée * Plein temps - Description de l'entreprise - SGS est une société internationale d'inspection, de vérification, de testing et de certification. Description du poste * Effectue les essais de conformité sur les matières premières ou produits finis. * Enregistre promptement, précisément et intégralement les données nécessaires à la traçabilité des opérations effectuées conformément aux procédures en vigueur (échantillons, réactifs, appareillages, initiales, dates). * Signale immédiatement tout résultat hors spécification au superviseur de laboratoire conformément à la procédure en vigueur. * Signale au plus vite au Team Leader tout besoin en matériel et réactifs. * Signa
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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
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.
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Nous recherchons actuellement un(e) : Quality Operations Lead(m/f) En tant que Quality Operations Lead, vous organisez le suivi des activités quotidiennes du département QC. * Manage * Contrat fixe à durée indéterminée * Plein temps - Nous offrons aux sociétés pharmaceutiques une large gamme de services sur mesure dans les domaines variés tels que les affaires réglementaires, la distribution et la promotion de produits pharmaceutiques ainsi que les services logistiques personnalisés. Basé à Manage, nous recherchons des profils talentueux et dynamiques pour compléter nos équipes et nous accompagner dans notre développement. Votre fonction - Dans ce rôle vous rapportez directement au . Garantir le bon déroulement des activités day to day du département * De la vérification qualité des réceptions de prod