Job Description

Dot\xc3\xa9s d\xe2\x80\x99une expertise in\xc3\xa9gal\xc3\xa9e en immunologie et pr\xc3\xa9sents en Am\xc3\xa9rique du Nord (c\xc3\xb4te Est et Ouest) et en Europe, Nexelis est l\xe2\x80\x99un des principaux prestataires de services dans le domaine du d\xc3\xa9veloppement et l\xe2\x80\x99analyse de tests biologiques sp\xc3\xa9cialis\xc3\xa9s en infectiologie, m\xc3\xa9tabolisme, et canc\xc3\xa9rologie. Notre \xc3\xa9quipe polyvalente de scientifiques, munie de plateformes technologiques \xc3\xa0 la fine pointe du progr\xc3\xa8s a jou\xc3\xa9 un r\xc3\xb4le essentiel dans le d\xc3\xa9veloppement, la qualification, validation de tests et leur utilisation en haut d\xc3\xa9bit dans plus de 100 dossiers associ\xc3\xa9s \xc3\xa0 l\xe2\x80\x99approbation par la FDA de nouvelles entit\xc3\xa9s mol\xc3\xa9culaires, comprenant des vaccins majeurs, des antiviraux et des produits d\xe2\x80\x99immunoth\xc3\xa9rapie, de th\xc3\xa9rapie g\xc3\xa9nique ou cellulaire.

Nous sommes pr\xc3\xa9sentement \xc3\xa0 la recherche d\xe2\x80\x99un candidat tr\xc3\xa8s motiv\xc3\xa9 qui poss\xc3\xa8de une vaste exp\xc3\xa9rience pour occuper le poste de sp\xc3\xa9cialiste en validation de syst\xc3\xa8mes informatis\xc3\xa9s. Ce poste rel\xc3\xa8ve du directeur associ\xc3\xa9, instrumentation & validation, et exige une connaissance approfondie des logiciels et du mat\xc3\xa9riel de laboratoire commercial.

Le r\xc3\xb4le principal est de fournir une expertise de haut niveau pour valider des syst\xc3\xa8mes informatis\xc3\xa9s et/ou automatis\xc3\xa9s, en conformit\xc3\xa9 avec les proc\xc3\xa9dures internes (e.g. Sant\xc3\xa9 Canada, US FDA CFR Part 11, EU Annex 11, etc.).

Principales responsabilit\xc3\xa9s

• R\xc3\xa9aliser la validation compl\xc3\xa8te de syst\xc3\xa8mes informatis\xc3\xa9s et/ou automatis\xc3\xa9s (y compris des logiciels d\xc3\xa9velopp\xc3\xa9s sur mesure) et d\xe2\x80\x99\xc3\xa9quipements de laboratoire ;
• Planifier, coordonner et ex\xc3\xa9cuter les projets de validation en collaboration avec les autres membres de l\xe2\x80\x99\xc3\xa9quipe, les op\xc3\xa9rations, l\xe2\x80\x99\xc3\xa9quipe des technologies de l\xe2\x80\x99information et l\xe2\x80\x99assurance qualit\xc3\xa9;
• R\xc3\xa9diger, r\xc3\xa9viser et ex\xc3\xa9cuter la documentation de validation (e.g. URS, FS, IQ/OQ/PQ) en fonction des besoins de l\'entreprise et des proc\xc3\xa9dures 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 syst\xc3\xa8mes informatis\xc3\xa9s conform\xc3\xa9ment aux proc\xc3\xa9dures internes.

Connaissances, comp\xc3\xa9tences et aptitudes

• Connaissance de Sant\xc3\xa9 Canada. GAMP5, 21CFR Part 11, et des bonnes pratiques de laboratoire en vigueur.
• Capacit\xc3\xa9 \xc3\xa0 \xc3\xa9tablir et ex\xc3\xa9cuter la strat\xc3\xa9gie de validation sur les activit\xc3\xa9s entourant le d\xc3\xa9ploiement des syst\xc3\xa8mes informatis\xc3\xa9s.
• Capacit\xc3\xa9 d\xe2\x80\x99analyser les exigences, d\xe2\x80\x99\xc3\xa9valuer les risques et de d\xc3\xa9terminer les livrables requis pour satisfaire les exigences de conformit\xc3\xa9.
• Excellentes aptitudes informatiques
• Bonnes aptitudes de planification, de priorisation et d\xe2\x80\x99analyse
• Capacit\xc3\xa9 de g\xc3\xa9rer plusieurs d\xc3\xa9ploiements de projets simultan\xc3\xa9ment.
• Excellentes aptitudes de communication
• Bon jugement du niveau de risque et de conformit\xc3\xa9
• Bon sens de l\xe2\x80\x99organisation, de la r\xc3\xa9solution de probl\xc3\xa8mes et de la prise de d\xc3\xa9cision. ;

Qualifications requises

• Excellentes aptitudes informatiques, des bases de donn\xc3\xa9es et l\xe2\x80\x99int\xc3\xa9grit\xc3\xa9 des donn\xc3\xa9es
• Excellentes comp\xc3\xa9tences en \xc3\xa9criture et en r\xc3\xa9solution de probl\xc3\xa8mes ;
• Capacit\xc3\xa9 de travailler m\xc3\xa9thodiquement dans un souci de pr\xc3\xa9cision et d\xe2\x80\x99exactitude
• Excellent travail d\'\xc3\xa9quipe, sens du service et comp\xc3\xa9tences organisationnelles ;
• Bilingue en anglais et fran\xc3\xa7ais.
• Formation acad\xc3\xa9mique en sciences de la vie ou en ing\xc3\xa9nierie ;
• Minimum de trois (3) ann\xc3\xa9es d\xe2\x80\x99exp\xc3\xa9rience en validation de syst\xc3\xa8mes informatis\xc3\xa9s pour usage r\xc3\xa8glement\xc3\xa9 dans l\xe2\x80\x99industrie pharmaceutique ;
• Exp\xc3\xa9rience en programmation d\xe2\x80\x99applications bas\xc3\xa9s sur des formulaires (e.g. C#, VB.Net, VBA) serait un atout

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.
We are currently looking for a motivated candidate with experience to fill the the System Validation and Testing Specialist role and provide validation expertise to implement, modify, decommission regulated equipment and computerized systems at the Laval Nexelis site while ensuring compliance with internal procedures and industry best practices (21-CRF Part11, GAMP5, NIST, GCLP, GLP, etc.).
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 external vendors.
• Administrate the facility environmental monitoring system.

What we are looking for:

• Bachelor\xe2\x80\x99s degree in life sciences or engineering a related field or equivalent experience
• Minimum 3 years experience working in a regulated pharmaceutical environment.
• Minimum 5 years experience validating computerized systems and laboratory equipment or related experience in quality assurance and testing
• High focus required in order to execute complex interventions autonomously.
• Ability to work methodically with a concern for precision and accuracy.
• Excellent analytical and problem-solving skills
• Proficient with office tools (Project, Visio, Outlook, Excel, Word, Power point)
• Fluently bilingual in English and French (both oral and written)
• Ability to plan, schedule and prioritize to ensure efficient delivery on multiple projects.
• Apply clinical trial, laboratory, and pharmaceutical processes and protocols as well as quality assurance processes and procedures, data storage and retrieval steps.
• Applicants must be legally authorized to work in Canada.

Q\xc2\xb2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.

IQVIA