Lutilisation du genre masculin a t adopte afin de faciliter la lecture et na aucune intention discriminatoire. NOUS SOMMES LA RECHERCHE D''UN SPCIALISTE VALIDATION IT...

Depuis plus de 30 ans,Neopharm Labsjoue un rle essentiel dans le dveloppement des produits de sant, grce son expertise enrecherche et dveloppement,testing analytique,analyses scientifiquesetconformit rglementaire.

Nous sommes reconnus pour notre engagement envers lesmeilleures pratiques de lindustrieet notre conformit auxrglementations nationales et internationales.

Neopharmoffre desservices danalyseaux fabricants deproduits pharmaceutiques,produits de sant naturelsetcosmtiques.

Nos systmes de qualit, constamment mis jour, garantissent des rsultatsrapides,fiablesetconformes aux normes les plus strictes, sur les marchsnationaux et internationaux.

Le spcialiste validation IT, s ous la supervision du superviseur Mtrologie, le spcialiste validation IT, assure la validation des systmes de laboratoire en crant et en mettant en uvre des protocoles, Data intgrit et des schmas directeurs pour des projets de validation.

Notre mission Soutenir les entreprises des sciences de la vie quelles soientmergentesoutablies dans leur qute dinnovation mdicale, avec une approche axe sur : larigueur latransparence laflexibilit lafiabilit Responsabilits principales Planifier, excuter et maintenir la validation des systmes informatiss ayant un impact GxP, incluant le matriel et les logiciels.

Rdiger les plans et protocoles de validation (VMP, VP, IQ/OQ/PQ).

Examiner et approuver les livrables de validation : URS, FRS, analyses de risques, protocoles et rapports.

Identifier, documenter et corriger les carts de validation, incluant lanalyse dimpact et les actions correctives (CAPA).

Rdiger des rapports de validation rsumant les rsultats, conclusions et recommandations. valuer les changements aux systmes laide dune approche base sur les risques et dterminer le niveau requis de revalidation.

Assurer la conformit lintgrit des donnes conformment aux exigences ALCOA+, BPF, FDA et 21 CFR Part 11.

Maintenir ltat de conformit des systmes tout au long de leur cycle de vie.

Rdiger, rviser et maintenir les SOP et politiques lies la validation des systmes informatiss.

Effectuer une veille rglementaire afin de rester jour sur les directives de lindustrie et exigences rglementaires.

Participer aux audits internes, clients et inspections rglementaires.

Collaborer avec les quipes TI, AQ, laboratoires et fournisseurs externes Toutes autres taches connexes Profil recherch Plus de 5 ans dexprience dans le secteur pharmaceutique et/ou des dispositifs mdicaux, en environnement rglement.

Minimum de 3 ans dexprience en validation des systmes informatiss (CSV) ayant un impact GxP.

Excellente matrise des processus de validation des systmes informatiques selon les lignes directrices ISPE GAMP 5, PIC/S et ICH.

Solide connaissance et application des Bonnes Pratiques de Fabrication (BPF).

Connaissance des rglements de Sant Canada et de la FDA.

Capacit dmontre appliquer une approche de validation base sur les risques, conforme aux standards internationaux.

Diplme universitaire en Informatique, sciences, ingnierie ou quivalent.

Exprience avec les systmes dentreprise utiliss en environnement laboratoire et qualit :



LIMS (Lab

Ware atout majeur) Systmes informatiss supportant les activits GxP Solide connaissance en Data Intgrit ; Excellente capacit danalyse et de documentation Autonomie et sens des priorits Excellente collaboration interfonctionnelle Rigueur et souci du dtail Capacit travailler sous la pression Bilingue (anglais et franais).

Pourquoi rejoindre Neopharm ? Une entreprise canadienne en pleine croissance dans les sciences de la vie.

Un environnement stimulant, ax sur linnovation et lexcellence.

Des projets denvergure avec des partenaires de renomme mondiale.

Une culture dentreprise fonde sur la qualit, la collaboration et le respect.

Unhoraire de travail flexible Unenvironnement dynamique et en constante volutionqui vous tient inform des dernires tendances de lindustrie Unprogramme complet davantages sociaux, incluant lassurance collective, un rgime de retraite avec contribution de lemployeur, et dautres avantages attrayants Unprogramme daide aux employset des services detlmdecine Le cot du transport en commun est rembours par lentreprise.

Vous souhaitez contribuer lindustrie des sciences de la vie et amliorer la sant des patients lchelle mondiale ? Rejoignez

Neopharm Labs, partenaire de confiance des grandes organisations du secteur. *Prenez note que votre CV sera partag au gestionnaire d''embauche, nous vous remercions pour votre intrt envers Neopharm Labs Inc, toutefois, nous communiquerons uniquement avec les candidats slectionns. #p1 The use of the masculine gender has been adopted to facilitate reading and is not intended to be discriminatory. WE ARE LOOKING FOR AN IT VALIDATION SPECIALIST...

For over 30 years,Neopharm Labshas played a vital role in the development of health products through its expertise inresearch and development,analytical testing,scientific analysis, andregulatory compliance.

We are recognized for our commitment toindustry best practicesand compliance withnational and international regulations.

Neopharm providesanalytical servicesto manufacturers ofpharmaceuticals,natural health products, andcosmetics.

Our continuously updated quality systems ensurefast,reliable, andcompliant resultsthat meet the highest standards in bothdomestic and international markets.

The IT Validation Specialist, reporting to the Metrology supervisor, is responsible for validating laboratory systems by creating and implementing protocols, data integrity procedures, and master plans for validation projects.

Our Mission To support life sciences companies whetheremergingorestablished in their pursuit of medical innovation, with an approach based on: Rigor Transparency Flexibility Reliability Key Responsibilities 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 Profile Sought 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 robust 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 timemanagement skills.

Strong crossfunctional collaboration and communication abilities.

High level of attention to detail and rigor.

Ability to perform effectively under pressure.

Bilingual in English and French.

Why Join Neopharm? 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 environmentthat keeps you informed of the latest industry trends Comprehensive benefits package, including group insurance, employer-contributed retirement plan, and other attractive perks Employee Assistance Programandtelemedicine services Public transportationcosts 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. #p1

📌 Spécialiste validation IT - IT validation spécialist (Blainville)
🏢 Neopharm Labs
📍 Blainville