Investigation Program Lead – Quality & RCA

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

Benefits offered by this job

Accommodation for disabilities

Pension plan

Bonus programs

Learning & development opportunities

Total Rewards package

Job summary

Apotex is a Canadian-based global health company headquartered in Toronto seeking an experienced investigator to conduct root-cause analyses on product quality investigations and customer complaints. The role emphasizes timely, thorough investigations with corrective and preventive actions, requiring strong RCCA skills and GMP knowledge.

You will interact with QA, RA, and manufacturing teams, lead investigations, prepare reports, and support escalation activities while ensuring compliance with

Qualifications

• Education in engineering/sciences or related technical field.
• Experience with RCCA tools and root-cause analysis.
• Knowledge of GMP and quality systems.
• Ability to manage multiple priorities in manufacturing.

Responsibilities

• Conduct investigations for complex product failures in manufacturing/packaging.
• Lead critical path identifications and write investigation reports.
• Coordinate escalation and communicate with QA, RA, and production.
• Prepare materials for Incident Response Committee meetings.
• Notify teams of validation and material failures and support investigations.
• Interface with customers and Apotex affiliates for notifications.

Skills

RCCA tools

Project management

Organizational skills

Interpersonal communication

Time management

Critical thinking

English language

GMP knowledge

Education

Post Secondary degree in Engineering, Sciences or related field

Tools

SAP

Microsoft Word

Microsoft Excel

Job description

Apotex is a Canadian-based global health company headquartered in Toronto seeking an experienced investigator to conduct root-cause analyses on product quality investigations and customer complaints. The role emphasizes timely, thorough investigations with corrective and preventive actions, requiring strong RCCA skills and GMP knowledge.

You will interact with QA, RA, and manufacturing teams, lead investigations, prepare reports, and support escalation activities while ensuring compliance with