Opties voor telewerken
Reistijd
... Min.
Sollicitatie methode
Taal van de job
Vaardigheden
Functiecategorie
Sector
Regio
Gemeente
Ervaringsniveau
Type contract
Voltijds/deeltijds
Voltijds
11
){kind=logo}
Must have the ability to independently analyse data and information to draw conclusions and make effective decisions.
){kind=logo}
Support in monitoring the value creation of the different businesses/projects by using financial indicators in financial models and by challenging their business plan while safeguarding uniformity in analyses and assumptions
){kind=logo}
Submission of materials for analysis and/or generation of analytical data using standard laboratory analyses.
Jefferson Wells * Braine-l'Alleud * Contract duration unspecified * Full Time - Contracting – Brabant-Walloon - Your responsibilities * Monitor the progress of plans and projects, GQA performance, and compliance through * meaningful KPIs. This will boost operational efficiency and agility. Ensure and track appropriate * data entry performance of audit reports and CAPAs in the Veeva audit system. * Enable insights for the company through data collection, entry, and analysis in the audit * management tool (e.g., trending, KPIs, etc.). * Curate data, including quality checks of audit management tool as needed, for * KPIs/metrics on performance and information on trending. * Ensure maintenance and improvement of quality of critical data within the Quality * Management System (includes data entry of audit related information and data * monitoring).
Developing method and performing analyses on active ingredient, drug product and excipients in the field of powder characterization * Independently planning, conducting and interpreting experiments to determine the bulk powder and particle properties of raw materials, intermediates and final dosage forms, by mastering a number of characterization tools: laser diffraction (wet and dry method) and microscopy (optical and SEM) for particle size and shape measurements; gas pycnometry and fine solid displacement methods for true and envelope density determinations; physisorption for surface area quantification and porosimetry; powder rheometry to assess powder flow stability and strain-rate dependency; shear cell testing to measure powder flow functions and wall friction with application to hopper design; surface energy and wettability analyses via contact ...
Deviations and Investigations: Manage deviations, root cause analyses, investigations, and changes related to processes. * Documentation: Manage documentation related to validations, analyses, and regulatory authority requests.
){kind=logo}
You possess excellent leadership and communication skills, along with the ability to analyse and drive performance improvements.
use your analytics expertise to conduct experiments and analyse results for our customers.
We hebben je zoekopdracht uitgebreid met 3 vacatures buiten de geselecteerde regio
){kind=logo}
To identify and analyse portfolio / segment trends within the Assistance business lines and to steer the Portfolio Management Process accordingly. * Proficiency in the use of Ms Word, Ms Excel, and PowerPoint for the creation of engaging analyses reports and presentations
AXA Partners * Belgium * Contract duration unspecified * Full Time - AXA Partners is an AXA transversal business unit offering a wide range of solutions in assistance services, travel insurance and credit protection. AXA Partners' role is also to implement innovative solutions emerging from the AXA Innovation unit. Combining passion with advanced expertise, we design and deliver worldwide solutions for and communities. We protect what matters, when it matters. Your responsibilities - The IT Business Analyst & IT Owner will be responsible for bridging the gap between IT and the business, following up integration between applications (Local or Global ones), manage application lifecycle during projects & BAU and also make sure that all Penetration Tests, DR Tests of applications are well planned, all information on ITPM is up to date and aligned with other tools (Ex: C-C
){kind=logo}
Indaver * Belgium * Contract duration unspecified * Full Time - Your tasks - What will your working day look like? As a Business Analyst SAP Authorization working at Indaver, no two days will be the same for you. You will translate business processes into IT solutions based on the demands of the business. You will follow projects through from end to end, from analysing the processes with the business and giving advice, including on potential problems, to providing solutions, implementation and documentation. You will use state-of-the-art systems, including SAP S4, a new identity management and provisioning platform,... . You will have every opportunity to develop your knowledge and soft skills further. You will work closely together with colleagues in other domains (Azure Entra/AD, HR,...) What will be your biggest challenge?
Deze jobs kunnen interessant zijn voor jou
Jefferson Wells * Braine-l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting - Brabant-Walloon - Vos responsabilités * Rédiger et mettre à jour les documents liés à la CCS * Organiser proactivement des réunions afin de collecter les informations auprès des * différents stakeholders (Production, Validation, Maintenance, Qualité, QC, MSAT…) * Développer un visuel afin de faire ressortir les éléments clés de la CCS (draft existant). * Ces documents doivent être finalisés pour l'inspection AFMPS de Juin. * Être en ordre de formation pour les activités dans le scope * Remonter tout problème significatif qui pourrait présenter un risque (qualité, coût, timing…). * Communiquer avec l'ensemble des pour assurer un mode de travail * coopératif. * Supporter les activités requises par le projet. Votre profil * Master * Bonnes connaissances des requis règlemen
){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
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
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
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
As a Digitalization Officer, you will assist in the implementation of an Electronic Batch Record (EBR) system for the visual inspection process within a plant. Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités - This project aims to transition from a paper-based documentation system to a fully digitalized process, ensuring enhanced traceability and efficiency. * Participate in the testing phase (Dry Run) of the EBR system by validating different sequences and ensuring compliance with expected outcomes. * Act as the Representative, bridging communication between the production floor, engineering, IT, and qualification teams. * Support the implementation of digital tools in the production environment. * Conduct technical testing and verification to ensure process effi
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
Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * Execution of routine analytical experiments and method development activities under supervision. * Follow established procedures and protocols. * Collaborate with in routine tasks. * Seek guidance for troubleshooting and problem-solving. * Decision-making, primarily under supervision. * Follows standard protocols under supervision. Identifies issues with guidance. * Support and assist in project/operation planning, data analysis, and coordination. * Follows project/operational plans and guidelines. * Assists in project tasks under supervision. * Collaborates with and provides status updates. * Sample management (availability in lab, shipment and reception). * Day to day lab experiment/resources planning and equipment booking in GT
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
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
Being one of the QA representatives for those activities and departments on the company site in case of alignment and level of quality related issues * Be one of the QA representatives in case of external audits regarding specific domain of knowledge (Master Data, purchasing, vendors management, warehouse, ... ) * In response to business requirements, identify, treat and communicate to QA and BTO management the possible issues of non-cGMP/21 CFR 820 compliance within Quality Management System and provide cGMP and QA expertise, interpretation and direction in order to create a framework of operational excellence enabling implementation of continuous improvement (e.g.: technical changes). * Train the company personnel regarding cGMP/21 CR 820 and Level of Quality requirements related to supply chain, purchasing, warehouse, operations, cold chain and SAP aspects.
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
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
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