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Validation Specialist
2 months ago
Position Title: Quality Assurance Engineer - Reports to the Director of Quality Assurance
Company Overview: Grifols is a leading global healthcare organization committed to enhancing the health and wellness of individuals around the globe. Established in 1909, Grifols is dedicated to advancing healthcare through innovative solutions and services across more than 100 countries.
Location: Montreal, Quebec, Canada
Role Overview:
- Accountable for the design, development, and execution of commissioning, qualification, and validation protocols in various domains including utilities, facilities, equipment, automation, processes, and cleaning validation.
- Offers technical guidance for change management, investigations, deviations, and corrective and preventive actions (CAPAs).
- Engages in intricate assignments necessitating comprehensive analysis and assessment.
- Oversees project delivery while adhering to quality standards, timelines, and budgetary constraints.
- Leads extensive projects or multiple initiatives with intricate characteristics.
- Provides training and mentorship on qualification and validation methodologies.
- Collaborates with diverse stakeholders both internally and externally.
- Exhibits a commitment to continuous improvement in professional knowledge and problem-solving capabilities.
- Demonstrates strong organizational, analytical, and communication proficiencies.
- Essential Qualifications: Bachelor’s degree in Applied Science or Engineering, specifically in Chemical Engineering, with a minimum of 8 years of pertinent experience in a GMP-compliant environment. Experience in qualification and validation processes is required.
- Proficiency in both French and English is preferred.