Quality Investigations Lead – RCCA & Compliance

APOTEX; Toronto; On-site; CAD 73,000 - 122,000; Full time

Benefits offered by this job

Bonus programs

Pension plan

Learning opportunities

Comprehensive benefits

Job summary

Apotex, a Canadian-based global health company, is seeking a Quality Investigator to independently conduct root cause analyses on investigations for OSD and to manage customer quality complaints in compliance with applicable regulations. You will review investigation reports for completeness and accuracy, ensuring timely corrective actions in a fast-paced manufacturing environment.

The role requires a post-secondary degree in engineering or sciences, GMP knowledge, strong RCCA and

Qualifications

• Post secondary degree in Engineering or Sciences or related field.
• Strong RCCA knowledge and project management skills.
• Excellent organization and problem-solving abilities.
• Fluent English, GMP awareness, and manufacturing experience.

Responsibilities

• Conduct investigations for complex product failures and write reports for approval.
• Notify team leaders of validation and material failures and provide guidance.
• Perform initial triage for criticality and escalate as needed.
• Coordinate with SMEs and prepare materials for incident reviews.
• Interface with customers to obtain information and provide updates.
• Manage investigations to completion with timely corrective actions.

Skills

RCCA tools

Project management

English proficiency

GMP knowledge

Team collaboration

Education

Post Secondary degree in Engineering or Sciences

Tools

SAP

Microsoft Word

Excel

Job description

Apotex, a Canadian-based global health company, is seeking a Quality Investigator to independently conduct root cause analyses on investigations for OSD and to manage customer quality complaints in compliance with applicable regulations. You will review investigation reports for completeness and accuracy, ensuring timely corrective actions in a fast-paced manufacturing environment.

The role requires a post-secondary degree in engineering or sciences, GMP knowledge, strong RCCA and