Quality Operations Specialist
il y a 2 semaines
F or the Quality Assurance Department of our Belgian site located in Braine-l’Alleud, we currently have an opening for an experienced Quality Operations Specialist - NPI. The key tasks are : Operations: Organize, manage and participate in QA activities from early-phase API manufacturing to Process Validation and in Cleaning activities, including:Review and approval of the documentation linked to quality agreements, process optimization & validation, analytical, operations and cleaning documentation to comply with the cGMP or other legislation, with PolyPeptide Quality System and customer requirementsManagement and approval of change controls, CAPAs & deviations and participation in on-line problem solving with other departments Release of API batches: GMP and Quality Work with counterparts from Strasbourg and other sites to establish common (best) practices in quality related systems, policies and procedures Recommend changes in practices to enhance the conformance to GMP within all departments Perform internal and external audits as required Hygiene, Safety and Environment In collaboration with safety department, ensure proper training of personnel in place in order to prevent risk of accident or failure during operations. People management and team spirit Experience in People Management Plan and prioritize the activities of the direct reports to minimize the production disturbance, meet the planning objectives as well as the Quality and Regulatory expectations. Ensure that the required and continuing training of the direct reports is carried out and adapted according to needs Motivate, listen to and manage the direct reports, maintaining a sound work spirit and manage relationship problems Implement "empowerment" and "full management" ways of life throughout the organization Evaluate annually the direct reports Information/Communication: Be the point of contact for customers quality topics (audits, customers requests, complaints and recalls) Inform management in case of any major quality or people management problem Make personnel aware of the importance of safety, environmental and GMP issues What we expect from you is : Master in Sciences with minimum 5 year experience in QA in a GMP Environment & NPI Fluency in French and English is mandatory (spoken and written English) Excellent command of Word, Excel and PowerPoint High organizational skills , good interpersonal skills, flexibility in tasks and schedules Sense of responsibility , enthusiasm, diplomacy and team spirit
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Quality Operations Specialist
il y a 6 heures
Braine-l'Alleud, Belgique PolyPeptide Belgium Temps pleinPolyPeptide Laboratories is a high-tech enterprise specializing in the development, manufacture and sale of **therapeutically active peptides**. PolyPeptide SA, Belgium, with approximately 320 employees is part of the international PolyPeptide Group with companies in Sweden, India, USA, France and Belgium. **F**or the Quality Assurance Department of our...
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Quality Operations Specialist
il y a 2 semaines
Braine-l'Alleud, Belgique PolyPeptide Temps pleinF or the Quality Assurance Department of our Belgian site located in Braine-l’Alleud, we currently have an opening for an experienced Quality Operations Specialist - Commercial. The key tasks are (among others): As a QA referent for products, the major accountabilities includes to Be the quality point of contact for customers and participate in the project...
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Quality Operations Specialist
il y a 6 heures
Braine-l'Alleud, Belgique PolyPeptide Belgium Temps pleinFor the Quality Assurance Department of our Belgian site located in Braine-l’Alleud, we currently have an opening for an experienced Quality Operations Specialist. **The key tasks are (among others)**: - Manage, listen to and motivate the QA Shopfloor team, maintaining a sound work spirit and discipline - Ensure that the required and continuing training...
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Quality Operations Specialist
il y a 6 heures
Braine-l'Alleud, Belgique PolyPeptide Belgium Temps pleinFor the **Quality Assurance** Department of our Belgian site located in Braine-l’Alleud, we currently have an opening for an experienced Quality Operations Specialist - Development and Validation. The primary goal of this function is to be the QA referent for Early Phase and Validation products and to perform activities of the QA Operation...
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Quality Operations Technician
il y a 2 semaines
Braine-l'Alleud, Belgique PolyPeptide Temps pleinPour le département Quality Assurance Operations, PolyPeptide SA est à la recherche d'un(e) Quality Operations Technician dont la fonction consiste à être l'interface entre les départements opérationnels et la QA, que ce soit en termes de revue documentaire, de coaching de l'esprit qualité, ou de la gestion des situations imprévues, d'être...
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Quality Control Specialist
il y a 7 heures
Braine-l'Alleud, Belgique UCB Temps plein**Make your mark for patients** **Nous cherchons un Spécialiste QC** qui est **minutieux, proactif et collaboratif** pour nous rejoindre dans notre équipe** Quality Control**, basé dans notre campus UCB situé à **Braine-l'Alleud, Belgique**. **À propos du rôle** En tant que Spécialiste QC, vous allez diriger des enquêtes de laboratoire, gérer...
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Head of External Clinical Supply Quality
il y a 3 semaines
Braine-l'Alleud, Belgique CareerWallet Temps pleinContracting – Brabant Wallon Operational Provide timely and efficient GMP/GDP IMP Release function to all relevant project activities related to the development of the pipeline projects (included all relevant activities for IMP release: label approval, batch record documentation, etc…). Support compliance with all relevant and appropriate regulations and...
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Clinical Supply Vendor Quality Lead
il y a 4 jours
Braine-l'Alleud, Belgique WhatJobs Temps pleinUCB Braine-l’Alleud, Walloon Region, Belgium Clinical Supply Vendor Quality Lead – Braine l’Alleud, Belgium To strengthen our Clinical Supply Quality department, we are looking for a talented profile to fill the position of: Clinical Supply Vendor Quality Lead – Braine l’Alleud, Belgium. About the Role As a member of the Clinical Supply Quality...
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Device Development Quality Lead
il y a 2 semaines
Braine-l'Alleud, Belgique UCB Temps pleinMake your mark for patientsTo strengthen our Devices and Wearable Tech Quality department we are looking for a talented profile to fill the position of: Device Development Quality Lead – Braine l’Alleud, BelgiumAbout the roleThis global role leads to operational Quality Assurance for the development and commercialization of medical devices,...
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External Manufacturing Operations Lead
il y a 2 semaines
Braine-l'Alleud, Belgique UCB Temps pleinMake your mark for patientsWe are looking for an External Manufacturing Operations Lead to join us in our External Manufacturing Department, based at Braine l’Alleud, Belgium or at Bulle, Switzerland.About the roleThe EMO lead is accountable for leading the operational management of UCB's selected global Contract Manufacturers Organizations & Strategic...
