QA Operation Specialist

il y a 1 semaine

Brainel'Alleud, Wallonie, Belgique Jefferson Wells Temps plein

Contracting – Brabant Wallon 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. Diplômé(e) de l'enseignement supérieur de type Bachelier ou Master (biotechnologie, pharmacie, etc.). Bilingue Français et Anglais. Expérience dans un environnement GMP. Bonnes connaissances des systèmes qualité (QMS) : Déviations, Change Control, CAPA. Bonnes connaissances des procédés de production Biotechnologiques (Upstream et/ou Downstream et/ou Logistique (Media/Buffer). Bonnes connaissances des processus de nettoyage (CIP/COP), de stérilisation (SIP), d'environmental monitoring, de thermal mapping de zone à température contrôlée. Jefferson Wells vous propose un contrat permanent en tant que consultant avec un package salarial attractif et vous donnera accès à des ... Français, Production, Logistique, Biotechnologie, Pharmacie, Rapport, Change Control, cGMP, Électronique, Surveillance, Bilingue, Stérilisation, QMS, Protocole, Enseignement, GMP, SIP, Assurance qualité, Validation Originele vacature is te vinden op StepStone.be – Maak nu een Jobagent aan op StepStone en vind je droombaan https://bit.ly/2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be Original job ad is published on StepStone.be - Set up a Jobagent at StepStone now and find your dream job https://bit.ly/2jPYsZC For similar jobs, information on employers and career tips visit StepStone.be La version originale de cette offre d'emploi est disponible sur stepstone.be – Créez maintenant votre Job Agent sur StepStone et trouvez le job de vos rêves https://bit.ly/2jPYsZC Trouvez des jobs similaires, des informations sur les employeurs qui recrutent et des conseils de carrière sur stepstone.be

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