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16
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- IT
- Kwaliteitsborging
- VOS
- GMP
- Productie
- Change Control
- (aankomend) intercedent
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- 1e verkoper
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- Capex Project Manager
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16 resultaten voor QA medewerker/ster in Gilly binnen een straal van 30 km
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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
Ensure follow-up and communication to QA Manufacturing teams of Deviations, Planned Deviations and Change Control related to Utilities, HVAC & Cleanrooms that could have an impact on manufactured batches * Support the Qualification & Validation activities for Utilities, HVAC & Cleanrooms and perform QA approval and QA authorization of related documentation.
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.
We hebben je zoekopdracht uitgebreid met 13 gelijkaardige vacatures.
Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * S'assurer du respect cGMP. * 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 * Participer activement à la préparation des lots de process performance qualification (PPQ). * 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.). * Expérience dans un environnement GMP. * Bonnes connaissances des systèmes qualité (QMS) : Déviations, Change Control, CAPA. * Bilingue en Français et Anglais. Notre offre
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
Comprendre et driver les aspects techniques de ce projet (et leader une équipe composée de chimistes, process engineers, automation engineer, electrical engineer, EHS, QA technique…) * Connaissance des normes EHS et QA applicables aux environnements de production.
Support QA activities for all QA entities ( Lab, pilot plant,…..) * Partner with QA and CMC Development/DCS colleagues to identify and mitigate Compliance risks, resolve potential regulatory observations. * QA/compliance experience in DS/DP/IMP manufacturing, facility operation, laboratory compliance and quality systems is an asset.
Plan and manage compliance tours and on the floor spot-check of the GMP area, offering quality assurance support including but not limited to inspection. * Drive the continuous QA improvement process. * Support Change Control and perform the QA evaluation * QA/compliance experience in DS manufacturing, facility operation, laboratory compliance and quality systems are an asset.
At least 5 to 8 years of experience of QA oversight in a GMP manufacturing environment
Interaction transversal entities (IT, Manufacturing, biological, chemical, QA, outsourcing Lead …)
Communicate with various (IT, Business, QA, QC).
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 * Act as the Operational QA link between selected external vendors within the Medical Device portfolio * 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 QA in the inspection/audit preparation activities, during inspection/audit and for closure of inspection/audit observation with associated CAPA commitments
Jefferson Wells * Braine l'Alleud * Contrat fixe à durée indéterminée * Plein temps - Contracting – Brabant Wallon - Vos responsabilités * Establish and build a network with the company key stakeholders in relation to Internal and External MSAT for Bio Drug Substances and Drug Products. * Troubleshooting and ensure issues are resolved in accordance with policies and procedures * Process improvement and life cycle management strategy within regulatory file boundaries * Process industrialization and Technical transfers within commercial manufacturing facilities * Complex investigations and CAPA plans implementation * Process validation oversight and continuous process verification (CPV) * Analytical method transfer and troubleshooting support. * Build, establish and develop a governance model and process for Quality oversight of Internal and External MSAT for Bio Drug S
Work closely with CPLO SMEs and QA teams to ensure deviations are adequately managed, according to the quality system guidelines and timely closed. Ensure close interface with QA, CS Compliance and CPLO teams. * Lead CPLO quality weekly meeting with management, SMEs and QA (Quality items review, SOP periodic reviews, training…). Participate in other CPLO TIER Meetings (QA, Prod...). * Participate in TIER meetings (Scheduling, QA, Prod...).
Participate as QA representative to the recurrent meetings, present issues and resolutions, and drive vendor quality performance through these meetings * Be the central QA point of contact for the organization for investigations / deviations / out-of-specifications / audit observations associated with the assigned vendors. Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders (the company Vendor Team, GQL, ILA, ALO, Business) to allow assessment. * Manage the key performance indicators (metrics) for key operational QA activities and services associated with the vendors in the defined described tracking tools ( QA KPI tracker, Spider Impact) and track the 's performance * Provide expert QA advice, suppo
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Manage Quality Assurance Agreement for New and On-going Supplier. * Partner with QA and CMC Development/CTS colleagues to identify and mitigate Compliance risks, resolve potential regulatory observations.
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