Quality Deviation & CAPA Specialist

Grifols

Mississauga

On-site

CAD 70,000 - 90,000

Full time

12 days ago

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Job summary

Grifols Canada is seeking a Deviation/CAPA Specialist to maintain regulatory-compliant Quality Systems across Canadian and EMA standards. You will oversee deviation and CAPA processes, lead investigations, and ensure timely closure while supporting KPI reporting and continuous improvement initiatives.

The role reports to the QMS Manager and requires a Bachelor’s in Health Sciences with GMP knowledge and 2+ years in pharma-quality environments.

Qualifications

  • Bachelor's degree in health-related sciences; pharmacy preferred.
  • Knowledge of quality management systems and processes.
  • GMP/cGMP knowledge preferred; pharma experience.
  • Typically 2+ years in GMP/quality roles.
  • Proficient with MS Office and quality documentation.

Responsibilities

  • Oversee deviation and CAPA management, ensuring timely closure and proper documentation.
  • Review and track deviation/CAPA records for compliance and timelines.
  • Monitor regulatory changes (Canada/EMA) and update the Quality System accordingly.
  • Assist in KPI collection, analysis, and reporting for Plasma Supply Chain quality metrics.
  • Support audits and inspections with evidence of compliance and quality records.
  • Collaborate with cross-functional teams to ensure proper investigation and corrective actions.

Skills

Quality Management
GMP Knowledge
Regulatory Understanding

Education

Bachelor's in Health Sciences

Tools

MS Office

Job description

Grifols Canada is seeking a Deviation/CAPA Specialist to maintain regulatory-compliant Quality Systems across Canadian and EMA standards. You will oversee deviation and CAPA processes, lead investigations, and ensure timely closure while supporting KPI reporting and continuous improvement initiatives.

The role reports to the QMS Manager and requires a Bachelor’s in Health Sciences with GMP knowledge and 2+ years in pharma-quality environments.

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