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36 resultaten voor Senior Product Owner in Waals Brabant binnen een straal van 30 km
We hebben je zoekopdracht uitgebreid met 36 gelijkaardige vacatures.
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Afin de renforcer son équipe Supply Chain, nous sommes à la recherche d'un Product Quality Specialist.
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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. * Contribute to project sub-team (DS, DP or analytical) as senior SME representing own area of expertise and actively contributing to the elaboration of project strategy. * To ensure process robustness, validation and transfer of NCEs and Lifecycle management of mat
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 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). * 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 preparat
Assurer la coordination de la validation des projets majeurs de TRD GMP en Drug Substance et Drug Product.
Responsible for all cGMP aspects related to the Utilities, HVAC & Cleanroom Systems owned by the System Owner. * Together with the Utilities, HVAC & Cleanroom System Owners, ensure direct follow of Compliance Audit activities, Deviations, Planned Deviations, Failure Investigations and Change Control related to the Utilities, HVAC & Cleanroom Systems
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Negotiate with site owners, grid operators, and suppliers.
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. * Identify, mitigate and subsequently resolve compliance and quality issues that may affect the company development activities and products. * A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
Evaluate risk and define remediation plan with system owner
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. * Be partner with other departments to identify, mitigate and subsequently resolve compliance and quality issues (Investigations / deviations / out-of-specifications) that may affect the company development activities and products. * A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
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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.) * Good knowledge about non-clinical safety evaluation of starting materials, synthesis intermediates and impurities, degradation products, leachables and extractables and associated guidelines.
Developer and Owner of the QA plans and product resource and capacity overview for activities associated with the assigned vendors - Maintain Quality Agreement with the vendors up to date and perform periodic reviews and update of the agreement in close collaboration with the product GQLs and the vendors. * When applicable, be sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the company Stability Program * Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed and are reviewed within the requested time period. * Participate on ad-hoc basis to the company Product Change Control Committees for activities related to the vendors * Cover the entire product life cycle from initial commercialization including Technology
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AISIN EUROPE is part of the Japanese AISIN Corporation, a leading supplier of automotive technology products employing more than 100,000 people worldwide. * Ideally 1 proven track record in business development of digital/high-tech products
All these activities will be performed in respect of the material and premises, in compliance with the HSE/Biosafety/GSP or GMP rules and with the regulatory requirements for each development phase of the product. * Previous development or validation of methods for viral vector products is a plus.
Support management of materials & product specifications, execute incoming materials release * Demonstrated ability to collaborate with senior to achieve optimal outcomes.
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 * 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 * Developing method and performing analyses on active ingredient, drug product and excipients in the field of powder characterization * Performing chemical imaging on drug product or intermediates
Establish and build a network with the company key stakeholders in relation to Internal and External MSAT for Bio Drug Substances and Drug Products. * 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 * Support assignments associated with the Products, or transversal projects across multiple Products * Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels.
Implement best practices and innovative solutions to improve product quality and operational performance.
Identification and definition of specific analytical tests in order to facilitate effective process development and ensure optimum product quality.
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.
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. * Identify, mitigate and subsequently resolve compliance and quality issues that may affect company development activities and products.
Maintain key performance indicators (metrics) for key operational development QA activities and services associated with the Medical Devices and Combination Products activities * Support Medical Devices and Combination Products related inspections
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Uw doelen zijn voornamelijk gericht op productie in investeringen (eenvoudig aanbod), omzetting van spaargeld in investeringen (Start to Invest), groei van het aantal investeerders in uw portefeuille en proactieve integratie van klanten in andere productcategorieën met ondersteuning van van betrokken . * U heeft een diepgaande kennis van basisproducten die verband houden met de functie (investeringen, bescherming, vermogen, dagelijks bankieren, enz.). U kent het risiconiveau van de producten of transacties die u aan uw klanten aanbeveelt.
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The overall purpose of Interogo Holding AG group is to manage investments with the aim of creating financial strength and build the reserves required to secure independence and longevity for their owner, Interogo Foundation.
Uw doelen zijn voornamelijk gericht op productie in investeringen (eenvoudig aanbod), omzetting van spaargeld in investeringen (Start to Invest), groei van het aantal investeerders in uw portefeuille en proactieve integratie van klanten in andere productcategorieën met ondersteuning van van betrokken . * U heeft een diepgaande kennis van basisproducten die verband houden met de functie (investeringen, bescherming, vermogen, dagelijks bankieren, enz.). U kent het risiconiveau van de producten of transacties die u aan uw klanten aanbeveelt.
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We are experts in our fields, and we draw on our knowledge and experience to create, design and manufacture our own products in our own studios and labs.