Quality Control Analyst Microbiology
5 months ago
With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we’re in shapes our lives, we are advancing dermatology for every skin story.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
Quality Quality Control Analyst Microbiology
Location : Baie D’Urfé, Canada
Description de poste:
Réaliser le contrôle qualité microbiologique sur les matières premières, les produits finis, les produits vrac, les fluides et effectuer les études de stabilité.
Principales responsabilités
- Réaliser des analyses physico-chimiques et/ou microbiologiques en utilisant les appareils et techniques d’analyse. Ces activités sont effectuées dans le respect du planning et des délais fixés.
- Préparer les échantillons / faire les prélèvements adéquats
- Pour chaque analyse, utiliser les techniques analytiques et appareils ou matériels nécessaires selon les méthodes et spécifications approuvées
- Interpréter les résultats des analyses : transcrire les résultats, appliquer les méthodes de calcul décrites dans les procédures, interpréter les résultats et vérifier leur cohérence
- Signaler les non-conformités ou les déviations sur les produits et les équipements utilisés, les évaluer et proposer des actions correctives et préventives
- Participer aux vérifications de résultats internes au laboratoire
- Documenter rigoureusement l’ensemble de son activité
- Effectuer toute autre activité de manière ponctuelle selon les besoins du service.
- Effectuer certaines tâches de niveau 2 de façon graduelle ou limité à certains aspects.
- Participer à l’optimisation de la gestion et de l’organisation du laboratoire
- Gérer les stocks de consommables, solvants, étalons et réactifs, si nécessaire
- Optimiser son temps de travail
- Gérer les déchets
- Participer au rangement, à l’ordre et à la propreté du laboratoire
- Nettoyer les appareils d’analyse et réaliser/suivre, si nécessaire, les tâches de maintenance (étalonnages, calibrages, petits dépannages, vérifications ), y compris lors des interventions de sociétés de maintenance et de fournisseurs
- Rédiger et mettre à jour la documentation (instructions d’utilisation, modes opératoires, procédures )
Skills & Qualifications
- Effectuer les taches de l’Analyste de laboratoire CQ-Microbiologie du niveau 1
- Planifier et participer aux activités du groupe CQ-Microbiologie en respect des priorités établies par le Gestionnaire Inspection et Validation et des délais standards établis.
- Assurer un soutien technique au Spécialiste CQ-Microbiologie et Gestionnaire CQ lors des investigations, non-conformités et OOS.
- Participer au suivi établissant les causes d’investigation ou déviation du groupe Micro ainsi qu’à la mise en place des correctifs établis.
- Participer à optimiser les méthodes d’analyse en ayant recours à la validation et au transfert des méthodes analytiques
- Maitrise l’ensemble des activités du laboratoire de microbiologie
- Être en mesure de faire la formation sur l’ensemble des activités de son secteur
- Être en mesure de mener à terme des mandats d’une complexité accrue de façon autonome tel validation de méthode.
- Être en mesure de servir comme délégué au gestionnaire ou spécialiste pour certains mandats complexes.
- Bonne maitrise de l’ensemble des procédures internes et des BPL dans un environnement pharmaceutique.
- Être en mesure de gérer des projets en faisant la planification et le suivi au cours des différentes étapes d’un projet.
- Participer à des groupes de trav
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