GxP Auditor – QA & CAPA Specialist

Fusion Pharmaceuticals; Hamilton; On-site; CAD 70,000 - 100,000; Full time

Job summary

A clinical-stage oncology company is seeking a GxP Auditor in Hamilton, Ontario. This role focuses on compliance within internal systems and requires at least 5 years in Quality Assurance with significant auditing experience. The ideal candidate will have strong regulatory knowledge, particularly of FDA and Health Canada standards, and excellent communication skills. Join this innovative team to enhance quality systems in a rapidly growing environment.

Qualifications

• Minimum of 5 years in pharmaceutical Quality Assurance.
• At least 3 years of direct auditing experience in GMP environments.
• In-depth understanding of FDA and Health Canada regulations.

Responsibilities

• Design and implement risk-based audit strategies.
• Perform detailed audits across various departments.
• Prepare for inspections by regulatory bodies.

Skills

Internal auditing of quality systems

Vendor audits

Communication skills

Regulatory knowledge

Education

Bachelor’s degree in Life Sciences

Job description

A clinical-stage oncology company is seeking a GxP Auditor in Hamilton, Ontario. This role focuses on compliance within internal systems and requires at least 5 years in Quality Assurance with significant auditing experience. The ideal candidate will have strong regulatory knowledge, particularly of FDA and Health Canada standards, and excellent communication skills. Join this innovative team to enhance quality systems in a rapidly growing environment.