System Validation and Testing Specialist

3 weeks ago

Laval, Canada IQVIA Full time

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 ;

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 reports and the proper remediation of any discrepancies with internal procedures and externa

  • System Validation and Testing

    1 month 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...

  • Quality Systems Specialist

    2 weeks ago

    Laval, Canada Bausch Health Companies Full time

    Quality Systems Specialist in Laval , Quebec Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians.Our team manufactures and markets a wide variety of pharmaceutical and health...

  • Quality Systems Specialist

    2 weeks ago

    Laval, Canada Bausch Health Companies Full time

    Quality Systems Specialist in Laval , Quebec Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians.Our team manufactures and markets a wide variety of pharmaceutical and health...

  • Quality Systems Specialist

    2 weeks ago

    Laval, Canada Bausch Health Companies Full time

    Quality Systems Specialist in Laval , Quebec Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians.Our team manufactures and markets a wide variety of pharmaceutical and health...

  • Quality Systems Specialist

    1 week ago

    Laval, QC, Canada Bausch Health Companies Full time

    Quality Systems Specialist in Laval , Quebec Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians. Our team manufactures and markets a wide variety of pharmaceutical and health products...

  • Quality Systems Specialist

    2 weeks ago

    Laval, Canada Bausch Health Full time

    Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians. Our team manufactures and markets a wide variety of pharmaceutical and health products that are distributed in pharmacies, healthcare...

  • Quality Systems Specialist

    2 weeks ago

    Laval, Canada Bausch Health Full time

    Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians. Our team manufactures and markets a wide variety of pharmaceutical and health products that are distributed in pharmacies, healthcare...

  • Quality Systems Specialist

    2 weeks ago

    Laval, Canada Bausch Health Full time

    Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians. Our team manufactures and markets a wide variety of pharmaceutical and health products that are distributed in pharmacies, healthcare...

  • Quality Systems Specialist

    2 weeks ago

    Laval, Canada Bausch & Lomb Full time

    Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians. Our team manufactures and markets a wide variety of pharmaceutical and health products that are distributed in pharmacies, healthcare...

  • Quality Systems Specialist

    1 week ago

    Laval, QC, Canada Bausch Health Full time

    Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians. Our team manufactures and markets a wide variety of pharmaceutical and health products that are distributed in pharmacies, healthcare...

  • Quality Assurance Specialist, Level Iii

    1 week ago

    Laval, Canada Prometic Full time

    At Prometic, employees work at saving lives, one role at a time. Located at the heart of the Cité de la Biotech in Laval, Prometic is in full growth-mode now that we are commercializing a treatment approved by the FDA for orphan diseases affecting children. This treatment, made of plasma-derived proteins, allows these children to have a new pathway to...

  • Ingénieur(e) test et validation

    1 month ago

    Laval, Canada INGTech Full time

    INGTECH est une firme d’ingénierie et de technologie spécialisée dans l’industrie du transport. Nous travaillons aux développements des véhicules du futures et au développement de solutions de gestion de flotte intelligente.Notre vision est de tracer la voie d’une industrie du transport plus intelligente, hautement optimisée et...

  • Quality - FACILITIES SPECIALIST FACILITIES SPECIALIST

    1 week ago

    Laval, QC, Canada Bausch Health Companies Full time

    Quality Systems Specialist in Laval , Quebec Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians. Our team manufactures and markets a wide variety of pharmaceutical and health products...

  • Quality Specialist

    1 month ago

    Laval, Canada Mecaer America inc. Full time

    **Quality Assurance Specialist** Mecaer America Inc. (MAI onwards), located in Laval, is an international provider of landing gear solutions for the helicopter business and aviation markets in general. Thanks to our certified expertise, we are a trusted partner for several customers worldwide including Bell Helicopter Textron, AgustaWestland, Safran Landing...

  • Quality Specialist

    1 month ago

    Laval, Canada Mecaer America inc. Full time

    **Quality Assurance Specialist** Mecaer America Inc. (MAI onwards), located in Laval, is an international provider of landing gear solutions for the helicopter business and aviation markets in general. Thanks to our certified expertise, we are a trusted partner for several customers worldwide including Bell Helicopter Textron, AgustaWestland, Safran Landing...

  • Process Validation Specialist

    4 weeks ago

    Laval, Canada Bausch Health Companies Full time

    Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians. Our team manufactures and markets a wide variety of pharmaceutical and health products that are distributed in pharmacies, healthcare...

  • Building Mechanical Controls Specialist

    1 month ago

    Laval, Canada Recrutement TOTEM Inc. Full time

    Advance your career while driving green building solutions! Totem seeks a Building Mechanical Controls Specialist to join a leading company focused on energy efficiency and professional growth. About the Company This company specializes in designing and building energy-efficient mechanical and HVAC systems for buildings. With a strong commitment to...

  • Building Mechanical Controls Specialist

    1 month ago

    Laval, Canada Recrutement TOTEM Inc. Full time

    Advance your career while driving green building solutions! Totem seeks a Building Mechanical Controls Specialist to join a leading company focused on energy efficiency and professional growth. About the Company This company specializes in designing and building energy-efficient mechanical and HVAC systems for buildings. With a strong commitment to...

  • Building Mechanical Controls Specialist

    1 month ago

    Laval, Canada Recrutement TOTEM Inc. Full time

    Advance your career while driving green building solutions! Totem seeks a Building Mechanical Controls Specialist to join a leading company focused on energy efficiency and professional growth. About the Company This company specializes in designing and building energy-efficient mechanical and HVAC systems for buildings. With a strong commitment to...

  • Validation Et Intégration Logicielle

    7 hours ago

    Laval, Canada amaris Full time

    Job description Nous recherchons des consultants dynamiques pour renforcer notre équipe en Ingénierie à Laval. Votre expérience, vos connaissances et votre engagement nous aideront à relever les défis de nos clients. Vous soutiendrez différents projets grâce à votre expertise en tant que Validation et Intégration Logicielle. **Vos principales...