System Validation and Testing

4 weeks ago

Laval, Canada Novasyte Full time

Spécialiste de la validation et des tests de systèmes

Dotés d’une expertise inégalée en immunologie et présents en Amérique du Nord (côte Est et Ouest) et en Europe, Nexelis est l’un des principaux prestataires de services dans le domaine du développement et l’analyse de tests biologiques spécialisés en infectiologie, métabolisme, et cancérologie. Notre équipe polyvalente de scientifiques, munie de plateformes technologiques à la fine pointe du progrès a joué un rôle essentiel dans le développement, la qualification, validation de tests et leur utilisation en haut débit dans plus de 100 dossiers associés à l’approbation par la FDA de nouvelles entités moléculaires, comprenant des vaccins majeurs, des antiviraux et des produits d’immunothérapie, de thérapie génique ou cellulaire.

Le rôle principal est de fournir une expertise de haut niveau pour valider des systèmes informatisés et/ou automatisés, en conformité avec les procédures internes (e.g. Santé Canada, US FDA CFR Part 11, EU Annex 11, etc.).

Principales responsabilités
- Réaliser la validation complète de systèmes informatisés et/ou automatisés (y compris des logiciels développés sur mesure) et d’équipements de laboratoire ;
- Planifier, coordonner et exécuter les projets de validation en collaboration avec les autres membres de l’équipe, les opérations, l’équipe des technologies de l’information et l’assurance qualité;
- Rédiger, réviser et exécuter la documentation de validation (e.g. URS, FS, IQ/OQ/PQ) en fonction des besoins de l'entreprise et des procédures internes ;
- Coordonner les interventions avec les fabricants et assurer la validation des modifications avant leur mise en service ;
- Assurer la surveillance environnementale et le support sur les systèmes informatisés conformément aux procédures internes.

Connaissances, compétences et aptitudes
- Connaissance de Santé Canada. GAMP5, 21CFR Part 11, et des bonnes pratiques de laboratoire en vigueur.
- Capacité à établir et exécuter la stratégie de validation sur les activités entourant le déploiement des systèmes informatisés.
- Capacité d’analyser les exigences, d’évaluer les risques et de déterminer les livrables requis pour satisfaire les exigences de conformité.
- Excellentes aptitudes informatiques
- Bonnes aptitudes de planification, de priorisation et d’analyse
- Capacité de gérer plusieurs déploiements de projets simultanément.
- Excellentes aptitudes de communication
- Bon jugement du niveau de risque et de conformité
- Bon sens de l’organisation, de la résolution de problèmes et de la prise de décision. ;

Qualifications requises
- Excellentes aptitudes informatiques, des bases de données et l’intégrité des données
- Excellentes compétences en écriture et en résolution de problèmes ;
- Capacité de travailler méthodiquement dans un souci de précision et d’exactitude
- Excellent travail d'équipe, sens du service et compétences organisationnelles ;
- Bilingue en anglais et français.
- Formation académique en sciences de la vie ou en ingénierie ;
- Minimum de trois (3) années d’expérience en validation de systèmes informatisés pour usage règlementé dans l’industrie pharmaceutique ;
- System validation and Testing specialist

With unrivaled expertise in immunology, and operating sites in North America (East and West Coast) and Europe, Nexelis, a Q2 Solutions company is a leading provider of assay development and advanced laboratory testing services in the infectious diseases, metabolic diseases, and oncology fields. Our versatile team of scientists, working with our advanced technology platforms, were instrumental in the development, qualification, validation, and large-scale sample testing of assays that supported the FDA filing of almost 100 new molecular entities, including blockbuster vaccines, anti-viral drugs, and immunotherapy, gene and cell therapy products.

Your main responsibilities:

- Write/Review/Approve validation deliverables (VP, URS, FS, RA, DS, UTCR, IQ/OQ/PQ, TM, VR, etc.) and ensure qualification execution according to business priorities and internal procedures.
- Lead multiple validation projects and coordinate their timely delivery with key stakeholders and external collaborators (team members, validation consultants, QA, IT, scientists, vendors)
- Ensure laboratory equipment and software life cycle management is carried out according to business strategy and internal procedures.
- Maintain regulated system access & train laboratory personnel in their operation with established procedures. Provide ad-hoc expert support on certain computerized systems.
- Diagnose hardware/software issues & devise solutions in close collaboration with scientific personnel and vendors.
- Administrate the facility & laboratory equipment maintenance program (calibration, preventive maintenance, repairs), ensure the timely review of all service rep

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