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Labelling and Change Management Specialist - Job Opportunity at Fresenius Kabi Canada

Toronto, Canada
Temporary
Mid-level
Posted: February 22, 2025
Hybrid
CAD 75,000 - 90,000 per year based on Toronto market rates for pharmaceutical quality specialists

Benefits

Hybrid work arrangement with 3 days on-site
Professional development through global organization exposure
Collaborative team environment
Opportunity for hands-on industry experience

Key Responsibilities

Manage change control processes for fabricator operations and regulatory compliance
Create and maintain product family dossiers
Oversee document change requests for bill of materials and master batch records
Coordinate with fabricators on testing and specification modifications
Support analytical method transfer activities
Manage vendor relationships with contract laboratories

Requirements

Education

Bachelor of Science degree in life science (chemistry and/or microbiology preferred)

Experience

Laboratory experience and prior pharmaceutical industry experience required

Required Skills

GMP knowledge Microsoft Office proficiency SAP experience (asset) Communication & customer service skills Organizational and problem-solving abilities Self-motivation Attention to detail Multitasking capability Results orientation
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Sauge AI Market Intelligence

Industry Trends

Increasing regulatory scrutiny in pharmaceutical labeling is driving demand for specialized change management roles Growing emphasis on digital documentation and compliance management systems in pharma manufacturing Rising importance of cross-functional collaboration between quality operations and regulatory affairs Trend toward integration of quality management systems with ERP platforms

Role Significance

Typically part of a 5-10 person quality operations team with matrix reporting to regulatory affairs
Mid-level specialist role with significant responsibility for compliance and quality outcomes

Key Projects

Implementation of new labeling compliance systems Harmonization of change control processes across multiple sites Regulatory documentation updates and maintenance Quality system optimization initiatives

Success Factors

Strong understanding of GMP requirements and regulatory frameworks Ability to manage multiple stakeholders across manufacturing and quality functions Excellent documentation and technical writing skills Strategic thinking in change impact assessment

Market Demand

High demand due to increasing regulatory requirements and pharmaceutical industry growth in Canada

Important Skills

Critical Skills

GMP compliance expertise - essential for maintaining regulatory standards Change management capabilities - core to role effectiveness Technical documentation skills - crucial for quality system maintenance Stakeholder management - key for cross-functional success

Beneficial Skills

Project management methodology Risk assessment techniques Quality management systems expertise Industry-specific software proficiency

Unique Aspects

Contract role with potential for permanent conversion
Exposure to global quality systems and processes
Opportunity to work with cutting-edge healthcare technologies
Integration of quality operations with manufacturing processes

Career Growth

2-3 years in role before advancement, depending on performance and organizational growth

Potential Next Roles

Quality Assurance Manager Regulatory Affairs Specialist Compliance Manager Quality Systems Lead

Company Overview

Fresenius Kabi Canada

Fresenius Kabi is a global healthcare company with strong presence in biosimilars, clinical nutrition, and medical technology

Leading position in healthcare solutions with presence in over 100 countries
Significant Canadian operations with focus on quality and regulatory excellence
Professional environment with emphasis on collaboration and innovation in healthcare delivery
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