About this role
<style type="text/css">table.MiTabla { max-width: 1020px;!important </style> <table border="0" cellspacing="0" cellpadding="0"> <tbody> <tr> <td><img src="https://staticweb.grifols.com/documents/675849/2554718/SSFF_16_CORP.jpg/cdab49ad-25d9-cb67-8db9-c818cbac0e62?t=1636640425166" alt="" align="top/"></td> </tr> <tr> <td> <p style="text-align:justify">Souhaitez-vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions.</p> </td> </tr> <tr> <td> <p style="text-align:justify">Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.</p> </td> </tr> <tr> <td><img src="https://staticweb.grifols.com/documents/675849/2554709/SuccesFactors_1020x93_jobposting_line_test.png/e2cffc87-a707-9e08-b5ef-081cae1f1ecf?t=1636640341637" width="100%"></td> </tr> </tbody> </table><p style="margin:0.0cm;font-size:12.0pt;font-family:Cambria, serif"><strong><span style="font-family:Calibri, sans-serif">Titre du poste :</span></strong><span style="font-family:Calibri, sans-serif"> Spécialiste, système qualité et conformité (Matériaux)</span></p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Cambria, serif"><strong><span style="font-family:Calibri, sans-serif">Relève de :</span></strong><span style="font-family:Calibri, sans-serif"> Superviseur, système qualité et conformité - Matériaux</span></p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Cambria, serif"> </p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Cambria, serif"><strong><span style="font-family:Calibri, sans-serif">Résumé :</span></strong></p> <p style="text-align:justify;margin:0.0cm;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Le spécialiste, système qualité et conformité – matériaux, contribue activement à l’évaluation et à la qualification des matériaux et des fournisseurs au sein du département Système qualité et conformité. Il apporte une expertise technique dans le cadre de projets, d’audits et d’activités de conformité, tout en assurant le respect des exigences réglementaires et des normes internes. Il participe à la collecte et à l’analyse de données afin d'aider le département à prendre des décisions et peut participer à la formation technique et non technique. D'autres tâches peuvent lui être assignées selon les besoins.</span></p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Cambria, serif"> </p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Cambria, serif"><strong><span style="font-family:Calibri, sans-serif">Principales responsabilités :</span></strong></p> <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Évaluer les matériaux et les fournisseurs conformément aux procédures établies. S'assurer que les matériaux sont conformes aux spécifications, aux exigences réglementaires et aux normes internes. </span><span style="font-family:Calibri, sans-serif">Produire et examiner les rapports d'évaluation des materiaux.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Peut procéder à l'évaluation annuelle des fournisseurs qualifiés sur la base de critères de qualité, de conformité et de performance.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Participer aux évaluations des risques liés aux matériaux et aux fournisseurs.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Tenir à jour la liste des fournisseurs agréés et veiller à leur conformité continue.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Apporter son soutien aux inspections réglementaires et aux audits clients, si nécessaire.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Soutenir la gestion et l'amélioration continue des systèmes, programmes ou projets liés à la qualité.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Veiller au respect des politiques et procédures de l'entreprise dans le cadre de son domaine d'expertise.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Fournir des conseils techniques sur les questions liées à la qualité et à la conformité.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Collaborer avec les équipes de fabrication, de réglementation et de production sur les questions liées aux bonnes pratiques de fabrication (GxP).</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Respecter les bonnes pratiques de fabrication (GMP) et les pratiques de sécurité du département.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Aider à la préparation de propositions et de recommandations à l'intention de la direction du département.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Peut enquêter et résoudre les problèmes de qualité liés aux matériaux et aux fournisseurs.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Rédiger et réviser les SOP et autres documents de qualité liés aux matériaux et aux fournisseurs.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Collaborer avec les départements de production, de contrôle qualité et autres sur des projets, des enquêtes sur les écarts, des CAPA, des contrôles des changements et des améliorations du système qualité.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Examiner et évaluer les notifications de changement fournisseur quant à leurs impacts qualité, réglementaires et opérationnels, et assurer la mise en œuvre et la documentation en temps opportun des actions requises.</span></li> </ul> <p style="margin:0.0cm;font-size:12.0pt;font-family:Cambria, serif"> </p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Cambria, serif"><strong><span style="font-family:Calibri, sans-serif">Qualifications requises :</span></strong></p> <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Baccalauréat en sciences, technologie, ingénierie ou mathématiques (STEM) ou expérience équivalente.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Minimum de 5 ans d’expérience pertinente dans le domaine de la qualité.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Expérience démontrée dans les systèmes qualité et la gestion de la qualité des matériaux ou de fournisseurs.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Excellentes compétences en communication écrite et orale.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Compréhension des exigences réglementaires et des lignes directrices nationales (p. ex. Santé Canada) et internationales (p. ex. FDA CFR) applicables.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Haut niveau d’intégrité et de rigueur professionnelle.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Bilinguisme français/anglais requis (la maîtrise de l’anglais est requise pour assurer les échanges de documentations et communications avec d’autres sites de Grifols hors Québec et hors Canada (Espagne, USA)</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Gère plusieurs tâches et établit efficacement les priorités afin de respecter les échéances</span></li> </ul> <p style="margin:0.0cm;font-size:12.0pt;font-family:Cambria, serif"> </p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Cambria, serif"> </p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Cambria, serif"><strong><span style="font-family:Calibri, sans-serif">Job Title:</span></strong><span style="font-family:Calibri, sans-serif"> Specialist, Quality System & Compliance (Materials)</span></p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Cambria, serif"><strong><span style="font-family:Calibri, sans-serif">Reports to:</span></strong><span style="font-family:Calibri, sans-serif"> Supervisor, Quality System & Compliance - Materials</span></p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Cambria, serif"> </p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Cambria, serif"><strong><span style="font-family:Calibri, sans-serif">Summary:</span></strong></p> <p style="text-align:justify;margin:0.0cm;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">The Specialist, Quality System & Compliance – Materials and Suppliers plays a key role in evaluating and qualifying materials and suppliers within the Quality System and Compliance department. This individual provides technical expertise in support of projects, audits, and compliance activities, ensuring adherence to regulatory requirements and internal standards. The specialist contributes to data collection and analysis to support departmental decision-making and may assist in delivering technical and non-technical training. Additional tasks may be assigned as needed.</span></p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Cambria, serif"> </p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Cambria, serif"><strong><span style="font-family:Calibri, sans-serif">Key Responsibilities:</span></strong></p> <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Perform evaluation of materials and suppliers according to established procedures. Ensure materials meet specifications, regulatory requirements, and internal standards. Generate and review commodity evaluation reports.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">May perform annual evaluation of qualified suppliers based on quality, compliance, and performance criteria.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Participate in risk assessments related to materials and suppliers.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Maintain the approved supplier list and ensure ongoing compliance.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">May participate in internal and supplier audits.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Support regulatory inspections and customer audits as needed.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Support the management and continuous improvement of quality systems, programs, or projects.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Ensure compliance with company policies and procedures within the scope of expertise.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Provide technical guidance on quality and compliance-related matters.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Collaborate with manufacturing, Quality Control, Quality assurance, and production teams on GxP-related issues.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Adhere to GMP and departmental safety practices.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Assist in preparing proposals and recommendations for the department’s leadership.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">May investigate and resolve quality issues related to materials and suppliers.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Draft and revise SOPs and other quality documents related to materials and suppliers.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Collaborate with production, quality control, and other departments on projects, deviation investigations, CAPAs, change controls, and quality system improvements.</span></li> <li style="line-height:15.0pt;margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:10.5pt;font-family:'Segoe UI', sans-serif">Review and evaluate Supplier Change Notifications for quality, regulatory, and operational impact, and drive timely implementation and documentation of required actions</span></li> </ul> <p style="line-height:15.0pt;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;margin-left:0.0px;font-size:12.0pt;font-family:Cambria, serif"> </p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Cambria, serif"><strong><span style="font-family:Calibri, sans-serif">Required Qualifications:</span></strong></p> <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Bachelor’s degree in a STEM field (Science, Technology, Engineering, Mathematics) or equivalent combination of education and experience.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Minimum of 5 years of relevant experience in quality systems.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Demonstrated experience in supplier and material qualification.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Strong written and verbal communication skills.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Understanding of applicable national (e.g., Health Canada) and international (e.g., FDA CFR) regulatory requirements and guidelines.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">High level of integrity and professionalism.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Bilingual in French and English (la maîtrise de l’anglais est requise pour assurer les échanges de documentations et communications avec d’autres sites de Grifols hors Québec et hors Canada (Espagne, USA)</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-family:Calibri, sans-serif">Manages multiple tasks, prioritizes effectively to meet deadlines</span></li> </ul> <table class="MsoNormalTable" style="width:100%;background-color:white;border-collapse:collapse" border="0" cellspacing="0" cellpadding="0"> <tbody> <tr style="height:27.0pt"> <td style="padding:6.0pt 0.0cm 6.0pt 0.0cm"> </td> </tr> </tbody> </table> <p style="margin:0.0cm;font-size:12.0pt;font-family:Cambria, serif"> </p> <p style="margin:0.0cm;font-size:12.0pt;font-family:Cambria, serif"> </p><p style="margin-bottom:11.0px"> </p> <p style="margin-bottom:11.0px"><img src="https://staticweb.grifols.com/documents/675849/2554709/SuccesFactors_1020x93_jobposting_line_test.png/e2cffc87-a707-9e08-b5ef-081cae1f1ecf?t=1636640341637" width="100%"></p> <p style="margin-bottom:11.0px"><a title="Politique de confidentialité de Canada" href="https://www.grifols.com/documents/6155530/7740235/Grifols+Canada+-+Careers+Privacy+Notice+FR.pdf/7cf80cab-8124-4560-83fc-21efdafa72a5?t=1753864058480" target="_self">Politique de confidentialité de Canada - Careers</a></p> <p style="margin-bottom:11.0px"><a 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