Manage deviations, CAPAs, and root cause analysis for Grifols’ regulated Quality System. Support compliance across Canadian and EMA requirements.
As a Deviation and CAPA Specialist reporting to the QMS Manager, you will oversee quality event management and documentation. The work includes regulatory monitoring, KPI reporting, investigation support, and continuous improvement. You will help maintain compliance with Grifols standards and applicable regulations.
Key Responsibilities: Manage approved deviation and CAPA systems
Coordinate investigations, root cause analysis, and corrective actions
Track records, timelines, documentation, and quality event closure
Monitor Canadian, EMA, and Grifols regulatory changes
Support audits with quality records, metrics, and compliance evidence
Requirements: Bachelor’s degree in health-related sciences, preferably Pharmacy
Minimum two years’ related GMP Quality Systems experience
Knowledge of Quality Management and preferred cGMP requirements
Proficiency with computers and Microsoft Office
Ability to follow, explain, and enforce SOPs
Apply quality systems expertise, regulatory awareness, and CAPA management skills to strengthen compliance at Grifols.