Quality Assurance Engineer
Core
Provide Quality Assurance oversight and support for commissioning, qualification, validation, technology transfer, process lifecycle management, capital projects, and operational quality activities to ensure compliance and successful project execution.
Role type
Quality Assurance Engineer (Regulatory/Validation)
Builds
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Domain
Pharmaceutical/Biotechnology/Medical Device Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP/GxP compliance, validation lifecycle management, GMP documentation review, risk assessment, change control, CAPA management, technology transfer support, vendor qualification, regulatory requirements knowledge (FDA/EMA/TGA/PIC/S), technical writing
Preferred skills
None stated
Technologies
None stated
Responsibilities
Provide QA oversight for engineering, validation, manufacturing, and capital project activities; Review and approve GMP-related documents including validation protocols and risk assessments; Support commissioning, qualification, and process lifecycle activities; Facilitate quality systems including deviations, investigations, and change controls; Ensure compliance with cGMP, GxP, and global regulatory requirements; Provide quality guidance and risk-based decision-making to project teams; Participate in audits, inspections, and continuous improvement initiatives; Support vendor qualification and supplier quality activities
Seniority
Mid-level, hands-on IC
