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.
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.
Titre du poste : Spécialiste, Assurance Qualité
Relève de : Gestionnaire, Assurance Qualité

QUALIFICATIONS:

• Education: At minimum, must have a B. Science, (Preferred: Microbiology, Chemistry, Biology)
• At least 2 - 3 years’ experience in QA within the Biopharmaceutical or Pharmaceutical manufacturing Industry
• Specialist level expertise with advanced knowledge of quality systems (change control, deviations, investigations, root cause analysis, CAPA and risk assessments)
• Demonstrates judgment, technical competence and knowledge critical for role
• Good computer skills with MS Office and Adobe Acrobat
• Strong organizational skills, including attention to detail and ability to meet deadlines
• Able to rigorously apply, follow and maintain rules, regulatory requirements, procedures and processes
• Must be able to work independently and as part of a team
• Able to multi-task while collaborating to achieve and exceed goals
• Leads improvement initiatives for organization’s practices, processes and quality
• Supports colleagues and actively engages with colleagues
• Facilitates cross-functional collaboration and manages assigned projects
• Good oral and written communication skills and good interpersonal skills
• Bilingual in both 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).
  Location: NORTH AMERICA : Canada : Montreal:CAQUEBEC - Quebec

• Perform the following day-to-day functions, but not limited to:
• Review of Deviations, Investigations, and CAPA
• Review of procedure, Batch Productions Records (BPRs), logbooks, reports, and any documentation generated by Manufacturing and other departments
• Review/Approval of Quality and Operations Activities and Documents (logbooks, room / equipment status, training records, investigations, etc.) in relation to Change Requests, and Deviations, Investigations, and CAPA, as needed
• Review/approval of quality systems such as Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, as well as provide Quality input for Validation projects.
• Coordinate periodic review of procedures and other quality documents
• Initiate Deviations, Investigations, CAPA, Change Requests related to GMP documents / processes, as required
• Ensure the integrity and traceability of all data generated and reported
• Generate new procedures and revise existing procedures, as required
• Gather Deviations, Investigations, CAPA and Change Request data for Annual Product Reviews
• Provide cross departmental support to production, QC, validation and engineering
• Develop and Report Quality Metrics for Deviations and other systems, as assigned
• Perform additional Quality System program responsibilities as trained on and assigned