On-Site QA SME: GMP Compliance & Batch Oversight

Virtue America; Toronto; On-site; CAD 90,000 - 130,000; Full time

Job summary

Virtue America in Canada is seeking an experienced Shop-Floor Quality Assurance (QA) SME to provide hands-on quality oversight across pharmaceutical manufacturing and packaging operations.

The role ensures compliance with cGMP, maintains batch documentation, supports deviation investigations, and collaborates with Manufacturing, Packaging, and Quality teams to drive quality improvements and maintain inspection readiness for Health Canada and FDA.

Qualifications

• 5+ years in pharmaceutical Quality Assurance on the shop floor.
• Strong knowledge of cGMP requirements and pharmaceutical manufacturing processes.
• Hands-on experience with batch record review, line clearance, equipment cleanliness verification.
• Familiar with GDP and ALCOA+ data integrity principles.
• Experience with deviation reporting, investigations, CAPA, and quality event management.
• Knowledge of Health Canada GMP requirements and FDA 21 CFR Parts 210, 211, and 11.
• Understanding of regulatory guidance (ICH Q7/9/10) and PIC/S GMP guidance.

Responsibilities

• Provide daily QA support on the manufacturing and packaging floors to ensure GMP compliance.
• Perform line clearance checks and verify equipment readiness before production activities.
• Review batch manufacturing and packaging records and address discrepancies promptly.
• Ensure activities comply with cGMP requirements and regulatory guidelines.
• Reinforce GDP and ALCOA+ data integrity in records and systems.
• Identify, document, and elevate deviations; support investigations and CAPA.
• Train production personnel on GMP requirements and documentation standards.
• Maintain inspection readiness for Health Canada and FDA inspections.
• Collaborate across QA, Manufacturing, and Packaging to resolve quality issues.

Skills

cGMP knowledge

QA on shop floor

GDP & ALCOA+

Deviation investigations

CAPA handling

FDA/HC awareness

Line clearance

Documentation skills

Job description

Virtue America in Canada is seeking an experienced Shop-Floor Quality Assurance (QA) SME to provide hands-on quality oversight across pharmaceutical manufacturing and packaging operations.

The role ensures compliance with cGMP, maintains batch documentation, supports deviation investigations, and collaborates with Manufacturing, Packaging, and Quality teams to drive quality improvements and maintain inspection readiness for Health Canada and FDA.