GMP documentation control is central to this Specialist role at Grifols in Winnipeg, supporting accurate, compliant quality records and tracking systems.
Reporting to the Quality Management System Manager, the Documentation Specialist supports QA document processing, filing, tracking, and archiving. You will maintain controlled documents, monitor activities affecting product quality, and support the quality management system. The work covers SOPs, forms, protocols, reports, and plasma supply chain documentation.
Key Responsibilities:
- Maintain GMP templates and document tracking systems
- Coordinate change control requests, approvals, preparation, and distribution
- Review Documentation Lifecycle System SOPs against Canadian requirements
- Compile Quality System key process indicator information
- Prepare Grifols viral marker data for PPTA reporting
Requirements:
- Bachelor's degree in health-related sciences
- Minimum two years' blood, plasma, or pharmaceutical experience
- Understanding of quality management systems and related regulations
- Knowledge of Health Canada, FDA, and EMA GMP regulations
- Microsoft Office Suite proficiency and strong communication skills
Apply documentation control, change management, and GMP knowledge to strengthen Grifols quality operations in Winnipeg.
GMP Documentation Control Specialist in Mississauga employer: Grifols
Grifols is an exceptional employer that prioritizes employee growth and development, offering a collaborative work culture in the heart of Toronto. As a leader in healthcare solutions, we provide our team with unique opportunities to engage in meaningful work that directly impacts public health while ensuring compliance with industry regulations. Join us to be part of a dynamic environment where your expertise will be valued and your contributions will help shape the future of healthcare.