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Quality Management System Specialist

$56k - $65k per year

Catalent

Quality Management System Specialist role at a newly launched pharmaceutical manufacturing facility in Ontario. Responsible for maintaining quality management systems, conducting supplier and compliance assessments, managing internal audits, and supporting continuous improvement initiatives in a regulated manufacturing environment.

Responsibilities

  • Maintain facility supplier assessment program by reviewing audit reports, complaints, and material reviews
  • Lead internal audit scheduling, support self-inspections, and assist with regulatory and customer audits
  • Participate in quality system areas including change control, document control, and customer regulatory inquiries
  • Support investigations and corrective actions for deviations and complaints with timely closure
  • Lead continuous improvement initiatives and develop new quality management systems and processes

Requirements

  • Diploma or bachelor's degree in life science or related field
  • Minimum 2 years of experience in Quality, Operations, or related field
  • Experience working in regulated pharmaceutical manufacturing environment
  • Knowledge of Good Manufacturing Practice compliance and regulatory requirements
  • Strong attention to detail and organizational skills
  • Proficiency with Microsoft Office Suite and quality management systems software
  • Excellent written and verbal communication abilities

Compensation: $56,000 – $65,000

Vacancy posted 13 days ago
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