QA Validation Specialist- Isolator Qualification

Resolute Workforce Solutions (Staff augmentation subsidiary of Brevitas Consulting Inc.) is dedicated to helping organizations achieve tangible results and lasting improvements via successful project delivery, continuous process improvement, and effective management of change. Our expertise is in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Project Management.

QA Validation Specialist - Isolator Qualification (Toronto, ON – On‑site)

Responsibilities

• Provide QA oversight for isolator qualification including IQ, OQ, PQ.
• Review and approve validation protocols, reports, deviations, and change controls.
• Assess qualification strategy for compliance with GMP and sterile manufacturing requirements.
• Make risk‑based QA decisions during execution of qualification activities.
• Support resolution of technical and compliance issues during commissioning and qualification...