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.

Key Responsibilities:

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
Requirements:
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.