QA Specialist, QC and Laboratory Equipment Qualification
Core
Provide Quality Assurance oversight for QC and laboratory equipment qualification activities to ensure GMP compliance and data integrity.
Role type
QA Specialist for laboratory equipment qualification
Builds
Qualified laboratory equipment and robust qualification documentation
Domain
Pharmaceutical manufacturing / GMP Quality
Required skills
GMP compliance, data integrity, risk assessment, IQ/OQ/PQ lifecycle management, change control, deviation management, documentation review, stakeholder management
Preferred skills
Experience in biotechnology, validation, automation/CSV, continuous improvement
Technologies
GDocP/cGDP, cGxP, URS, CAPA
Responsibilities
Review and approve qualification documentation (protocols, reports, deviations, CAPAs), support equipment lifecycle management (qualification, requalification, change assessments), provide QA guidance during qualification execution, identify compliance risks, drive continuous improvement initiatives
Seniority
Mid-level, hands-on IC
