Night Shift QA Specialist - GMP & Quality Assurance

Sanofi; Toronto; On-site; CAD 76,000 - 110,000; Full time

Job summary

Sanofi in Toronto, ON seeks a Quality Assurance Specialist for nights (Mon-Fri, 12am–8am) on a fixed-term 12-month assignment. This role emphasizes GMP review, batch release, and robust quality systems to safeguard patient safety and product quality.

The successful candidate will collaborate with production teams, lead RCA investigations, support regulatory inspections, and drive continuous quality improvement across operations with a strong shopfloor presence.

Qualifications

• Bachelor's degree or higher in a scientific field.
• 2–5+ years of experience in pharmaceutical quality assurance or operations.
• Knowledge of cGMP and GxP regulations in a regulated pharma environment.
• Experience with quality documentation, compliance activities, and regulatory requirements.

Responsibilities

• Ensure activities comply with GMP and regulatory requirements.
• Conduct regular audits of production processes to identify quality issues.
• Collaborate with production to maintain quality across the product lifecycle.
• Lead investigations for quality incidents and implement preventive actions.
• Participate in internal and external audits and inspections with documentation support.

Skills

Quality Assurance

Change Control

Root Cause Analysis

Regulatory Requirements

Documentation Review

Risk Management

Education

Bachelor's degree in Pharmacy/related field

Job description

Sanofi in Toronto, ON seeks a Quality Assurance Specialist for nights (Mon-Fri, 12am–8am) on a fixed-term 12-month assignment. This role emphasizes GMP review, batch release, and robust quality systems to safeguard patient safety and product quality.

The successful candidate will collaborate with production teams, lead RCA investigations, support regulatory inspections, and drive continuous quality improvement across operations with a strong shopfloor presence.