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Company | Grifols |
Address | Montreal, Quebec, Canada |
Employment type | FULL_TIME |
Salary | |
Category | Medical Equipment Manufacturing,Pharmaceutical Manufacturing |
Expires | 2023-07-24 |
Posted at | 10 months ago |
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
- Develop metric and benchmarking reports for presentation to top management. Proactively evaluate systems for trends and adverse findings. Identify, drive and implement improvements that result in sustainable compliance.
- I nterface with various groups to ensure that content in complex technical submissions and information requests to Health Canada, FDA and other regulatory agencies is accurate and complete.
- P rovide guidance and scientific/technical advice regarding validations and validation deviations as needed.
- Evaluate and assess change controls to determine applicable requirements and assist in determining regulatory reporting classification and requirements.
- Identify, drive and implement process and system improvements.
- P ractice high level of facilitations skills to reach consensus and works toward solutions.
- R eview and approve technical protocols and reports including stability, characterization and validation studies.
- P articipate in regulatory and internal inspections/audits including direct discussions with auditors and providing written responses as applicable for area of responsibility.
- Maintain current knowledge of FDA, EU and other regulatory agencies and industry standards.
- Oversee and manage the QA Department and provide support, direction and coaching to team members.
- Author and/or edit Standard Operation Procedures (SOPs), License Specifications (LSs), risk assessments, regulatory submissions and other documents.
- Communicate with cross functional departments and support groups to improve departmental performance and efficiency.
- Excellent communication skills (written and verbal)
- Bilingual in both French and English preferred.
- Experience interacting with Regulatory Agency Investigations.
- PHD in a Life Sciences or relevant degree with minimum of 6 years relevant experience. MSc in a Life Sciences or relevant degree with minimum of 8 years relevant experience. BSc in a Life Sciences or relevant degree with minimum of 10 years relevant experience.
- Proficiency with Microsoft office including Word, Excel and PowerPoint.
- Extensive working knowledge of domestic (i.e. Health Canada) and applicable foreign regulatory agency requirements/guidelines (FDA)
- 10 years of professional experience in pharmaceutical lab or manufacturing areas which include supervisory experience.
- Fournir une orientation et des conseils scientifiques et techniques concernant les validations et les écarts de validation, au besoin ;
- Maintenir une connaissance à jour de la FDA, de l’UE et d’autres organismes de réglementation et normes de l’industrie ;
- Identifier, piloter et mettre en œuvre des améliorations des processus et de systèmes ;
- Gérer et superviser tous les aspects des opérations d’assurance qualité du Service AQ et fournir le support, la direction et le coaching aux employés de l’équipe QA ;
- Rédiger et/ou éditer des procédures d’utilisation normalisées (SOPs), des spécifications de licences, évaluations de risques, soumissions réglementaires et autres documents ;
- Assurer l’interface avec divers groupes pour s’assurer que le contenu des présentations techniques complexes et des demandes de renseignements à Santé Canada, à la FDA et à d’autres organismes de réglementation soit exact et complet ;
- Examiner et approuver les protocoles et les rapports techniques, y compris les études de stabilité, de caractérisation et de validation ;
- Participer aux inspections et aux vérifications réglementaires et internes, y compris des discussions directes avec les vérificateurs et fournir des réponses écrites, le cas échéant, dans le domaine de responsabilité ;
- Évaluer et évaluer les contrôles des changements afin de déterminer les exigences applicables et d’aider à déterminer la classification et les exigences réglementaires en matière de rapports ;
- Communiquer avec les ministères inter-fonctionnels et les groupes de soutien pour améliorer la performance et l’efficacité du département ;
- Exercer un haut niveau de compétences en facilitation pour parvenir à un consensus et travailler vers des solutions ;
- Élaborer des rapports de mesure et d’analyse comparative pour présenter à la direction. Évaluer de manière proactive les systèmes pour les tendances et les résultats défavorables. Identifier, mener et mettre en œuvre des améliorations qui se traduisent par une conformité durable.
- Bilinguisme français et anglais de préférence.
- 10 ans d’expérience professionnelle en labo pharmaceutique ou en environnement manufacturing incluant de l’expérience de supervision ;
- Doctorat en sciences de la vie ou diplôme pertinent avec un minimum de 6 ans d’expérience pertinente. MSc dans un diplôme en sciences de la vie ou diplôme pertinent avec un minimum de 8 ans d’expérience pertinente. BSc dans un diplôme en sciences de la vie ou diplôme pertinent avec un minimum de 10 ans d’expérience pertinente ;
- Excellentes compétences en communication (écrit et verbal)
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- Expérience en termes d’interactions efficaces lors de vérifications des Agences Réglementaires ;
- Connaissance pratique approfondie des exigences et des lignes directrices des organismes de réglementation nationaux (c.-à-d. Santé Canada) et étrangers applicables (c.-à-d. la Food and Drug Administration) ;
- Très bonne connaissance de la suite Microsoft Office incluant Word, Excel et PowerPoint ;
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