Computerized Systems Validation Specialist

5 months ago


Montréal, Canada GenAIz Full time

Le Groupe Uni3T est une société informatique jeune et dynamique qui est active dans les secteurs des sciences de la vie et de l'industrie pharmaceutique. L'entreprise est née d'une volonté de réunir et d'unifier sous un même toit une expertise complète dans le domaine des sciences de la vie. Notre mission est d'améliorer l'accès aux soins et aux produits de santé en fournissant des services de consultation et des solutions technologiques aux entreprises des sciences de la vie.

Notre approche repose sur trois axes principaux. Toutes nos missions commencent par l'obtention d'une vision stratégique hautement alignée avec les besoins de nos clients. Nous travaillons avec nos clients sur la transformation de leurs processus afin de libérer le plein potentiel organisationnel. Enfin, notre équipe s'occupe du déploiement des technologies pour optimiser la chaîne de valeur de l'entreprise grâce à l'automatisation des processus clés, tout en assurant leur conformité réglementaire aux instances applicables.

Nous sommes à la recherche d'un talent pour se joindre à notre équipe de services professionnels. Ce professionnel travaillera au sein de notre équipe de spécialistes CSV sur les projets de validations de systèmes informatisés (CSV) dans un environnement réglementé.

**Responsabilités**:

- Effectuer des vérifications et des examens des documents de commissioning, qualification et validation pour les systèmes et les processus de nos clients
- Coordonner les projets CSV pour les logiciels et les systèmes automatisés
- Élaborer des stratégies et des plans de validation
- Coordonner les activités des différentes parties prenantes (département informatique, SMEs, utilisateurs finaux, unité qualité, fournisseurs)
- Effectuer une analyse des risques et définir le processus de qualification
- Rédiger et examiner les évaluations des risques et les scripts de test applicables conformément aux directives de conformité des GxP (BPF) et du CFR partie 11 et aux procédures de validation
- Élaborer et réviser des livrables du cycle de développement logiciel (SDLC), tels que : plans de validation, requis, spécifications, matrices de traçabilité, protocoles de test (IQ, OQ et PQ), rapports de qualification.
- Exécuter et réviser des protocoles de qualification pour assurer la conformité et le respect des lignes directrices applicables
- Participer à la résolution des déviations aux protocoles et procédures
- Examiner et modifier les procédures d'opération normalisées (SOPs)
- Communiquer les approches et les exigences du CSV pendant les réunions et les ateliers
- Développer et effectuer les formations clients

**Qualifications et compétences requises**:

- Maîtrise du français et de l'anglais écrits et parlés
- Solides compétences en communication et en relations interpersonnelles
- Intéressé à contribuer à l'entreprise tout en apprenant
- Proactif et organisé
- Soucieux du détail
- Fait preuve d'initiative
- Minimum de 2 ans d'expérience de travail dans les sciences de la vie ou l'industrie pharmaceutique
- Baccalauréat en informatique (sécurité, infrastructure, logiciel), génie (chimie, biomédical, biotechnologie, etc.) ou sciences de la vie (biochimie, chimie, pharmacie, etc.)

**Avantages**:

- Salaire de base compétitif + bonus (basé sur la performance de l'entreprise, de l'équipe et des efforts individuels)
- Couverture d'assurance complète par RBC
- Cotisations REER
- Poste permanent à temps plein
- Remboursement du forfait téléphone mobile
- Culture d'entreprise dynamique avec des opportunités de développement de carrière
- Politique de travail hybride (selon les besoins de l'équipe et des clients)
- Évenements d'entreprise réguliers.

**Exigences**:
- Peut être amené à se déplacer dans la grande région de Montréal jusqu'aux bureaux des clients.Uni3T Group is a young and dynamic IT company active in the life sciences and pharmaceutical industries. The company was born out of a desire to bring together and unify under one roof a complete expertise in the field of life sciences. Our mission is to improve access to health care and products by providing consulting services and technology solutions to life science companies.

Our approach is based on three main axes. Our missions begin with obtaining a strategic vision aligned with the needs of our customers. We work with our clients on transforming their processes to unlock the full organizational potential. Finally, our team takes care of the deployment of technologies to optimize the company's value chain through the automation of key processes, while enforcing regulatory compliance to all applicable regulations.

We are looking for a talent to join our professional services team. This professional will work with our team of CSV specialists on computerized systems validation (CSV) projects in a regulated environment.

**Responsibilities**:

- Perform commissioning, qualifi


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