Spécialiste validation IT - IT validation spécialist

L’utilisation du genre masculin a été adoptée afin de faciliter la lecture et n’a aucune intention discriminatoire.

NOUS SOMMES À LA RECHERCHE D'UN SPÉCIALISTE VALIDATION IT…

Depuis plus de 30 ans, Neopharm Labs joue un rôle essentiel dans le développement des produits de santé, grâce à son expertise en recherche et développement, testing analytique, analyses scientifiques et conformité réglementaire. Nous sommes reconnus pour notre engagement envers les meilleures pratiques de l’industrie et notre conformité aux réglementations nationales et international es.

Neopharm offre des services d’analyse aux fabricants de produits pharmaceutiques, produits de santé naturels et cosmétiques. Nos systèmes de qualité, constamment mis à jour, garantissent des résultats rapides, fiables et conformes aux normes les plus strictes, sur les marchés nationaux et internationaux.

Le spécialiste validation IT, sous la supervision du superviseur Métrologie, assure la validation des systèmes de laboratoire en créant et en mettant en œuvre des protocol es, dossiers d’intégrité des données et des plans maîtres pour les projets de validation.

Soutenir les entreprises des sciences de la vie — qu’elles soient émergentes ou établies — dans leur quête d’innovation médicale, avec une approche axée sur :

• la rigueur
• la transparence
• la flexibilité
• la fiabilité

• Plan, execute, and maintain the validation of GxP-impacting computerized systems, including both hardware and software.
• Develop and author validation plans and protocols (VMP, VP, IQ/OQ/PQ).
• Review and approve validation deliverables, including URS, FRS, risk assessments, protocols, and validation reports.
• Identify, document, and remediate validation deviations, including impact assessment and implementation of Corrective and Preventive Actions (CAPAs).
• Prepare validation summary reports outlining results, conclusions, and recommendations.
• Assess system changes using a risk-based approach and determine the appropriate level of revalidation required.
• Ensure data integrity compliance in accordance with ALCOA+ principles, GMP, FDA regulations, and 21 CFR Part 11.
• Maintain the validated state of systems throughout their lifecycle.
• Draft, review, and maintain SOPs and policies related to computerized system validation.
• Perform regulatory and industry guideline surveillance to remain current with evolving compliance requirements.
• Participate in internal audits, client audits, and regulatory inspections.
• Collaborate closely with IT, Quality Assurance, laboratory teams, and external vendors.
• Perform other related duties as required.

• More than 5 years of experience in the pharmaceutical and/or medical device industry, within regulated environments.
• Minimum of 3 years of experience in Computer System Validation (CSV) for GxP-impacting systems.
• Strong expertise in computerized system validation processes in accordance with ISPE GAMP 5, PIC/S, and ICH guidelines.
• Solid knowledge and practical application of Good Manufacturing Practices (GMP).
• Thorough understanding of Health Canada and FDA regulations.
• Proven ability to apply a risk-based validation approach aligned with international regulatory standards.
• University degree in Computer Science, Life Sciences, Engineering, or equivalent.
• Experience with enterprise systems used in laboratory and quality environments, including:
  • LIMS (Lab Ware – strong asset)
  • Computerized systems supporting GxP activities
• Strong knowledge of Data Integrity principles (ALCOA+).
• Excellent analytical and technical documentation skills.
• Ability to work independently with strong prioritization and time‑management skills.
• Strong cross‑functional collaboration and communication abilities.
• High level of attention to detail and rigor.
• Ability to perform effectively under pressure.
• Bilingual in English and French.

• A growing Canadian company in the life sciences sector
• A stimulating environment focused on innovation and excellence
• High-impact projects with globally recognized partners
• A corporate culture built on quality, collaboration, and respect
• Flexible work schedule
• Dynamic and fast-paced environment that keeps you informed of the latest industry trends
• Comprehensive benefits package, including group insurance, employer-contributed retirement plan, and other attractive perks
• Employee Assistance Program and telemedicine services
• Public transportation costs reimbursed by the company

Are you ready to contribute to the life sciences industry and help improve global health?

Join Neopharm Labs, a trusted partner of leading organizations in the sector.

* Please note that your resume will be shared with the hiring manager. We thank you for your interest in Neopharm Labs Inc., but only selected candidates will be contacted.