Quality Assurance Investigations Specialist

Lead pharmaceutical quality investigations at Sun Pharma using root-cause analysis and risk assessment in an office-based setting. Address complex non-conformities with regulatory focus.

The Quality Assurance Investigations Specialist ensures products meet GMP, Company, and regulatory requirements. You will manage deviations, establish effective CAPAs, and apply pharmaceutical Quality Systems. The position involves Track Wise, certification activities, cross-department coordination, and communication with Health Canada and FDA officials. A Bachelor’s Degree in Science or a related discipline is required.

• Identify root causes and execute investigation risk assessments
• Manage non-conformity recognition, investigation, and resolution
• Assess CAPA effectiveness and execute associated actions
• Coordinate subject matter experts and investigation Board discussions
• Participate in internal, customer, and regulatory audits

• Bachelor’s Degree in Science or related discipline
• Minimum one year pharmaceutical Quality Assurance, Quality Control, or Manufacturing experience
• Working knowledge of pharmaceutical Quality Systems
• Knowledge of standards, transfer guidelines, and validation requirements
• Experience with Track Wise, LMS, EDMS, or SAP is an asset

Apply pharmaceutical investigation, CAPA, and Quality Systems expertise to support compliant manufacturing at Sun Pharma.