Quality Assurance Specialist
Core
Provide Quality Assurance oversight and support for commissioning, qualification, validation, technology transfer, and process lifecycle management in regulated industries.
Role type
Quality Assurance Specialist (Contract)
Builds
compliant pharmaceutical/biotech products and processes
Domain
Life Sciences / Pharmaceutical / Biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP/GxP compliance, validation lifecycle management, GMP document review, risk assessment, change control, CAPA management, technology transfer support, vendor qualification, regulatory knowledge (FDA/EMA/TGA/PIC/S), technical writing
Preferred skills
engineering or life science background, stakeholder relationship building, problem-solving, strategic decision-making
Technologies
cGMP, GxP, FDA, EMA, TGA, PIC/S
Responsibilities
Provide QA oversight for engineering, validation, manufacturing, and capital projects; Review and approve GMP-related documents including validation protocols and risk assessments; Support commissioning, qualification, and technology transfer activities; Facilitate quality systems including deviations, investigations, and change controls; Ensure compliance with global regulatory requirements; Collaborate with cross-functional teams to achieve project objectives; Participate in audits and continuous improvement initiatives.
Seniority
Mid-level, hands-on IC