Quality Assurance Associate – Pharmaceutical

About the role

The Quality Assurance Associate will support Auro Pharma’s QA team in maintaining compliance with Health Canada GMP requirements and international regulatory standards. You will help implement and sustain the Pharmaceutical Quality System, ensuring product quality, patient safety, and regulatory compliance throughout the product lifecycle.

Key responsibilities

• Review batch release documentation, including CoAs, CoCs, batch records, packaging records, and laboratory results.
• Coordinate with manufacturing sites, CMOs, laboratories, warehouses, and global QA teams to facilitate timely batch disposition and release.
• Ensure batch release activities meet Health Canada requirements for imported drug products and GMP guidelines.
• Support the implementation and maintenance of the Quality Management System (QMS) in line with Health Canada GMP.
• Maintain GMP documentation according to Good Documentation Practices (GDP).

Required profile

• 2‑4 years of experience in pharmaceutical quality assurance or a related field.
• Strong knowledge of GMP principles, quality systems, and Health Canada regulatory requirements.
• Familiarity with sterile and non‑sterile dosage forms.
• Ability to work collaboratively with internal departments, CMOs, testing labs, and global quality teams.

Required skills

• Good Manufacturing Practices (GMP)
• Good Documentation Practices (GDP)
• Quality Management System (QMS) implementation
• Health Canada regulatory knowledge