Quality Management System Specialist
$56k - $65k per yearCatalent
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
$56k - $65k per year
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