QA Compliance Specialist
Core
Ensure Abbott products meet regulatory standards and comply with GMP and internal requirements to maintain product quality and patient safety.
Role type
QA Compliance Specialist (Regulatory)
Builds
Regulatory dossiers and quality documentation for pharmaceutical products
Domain
Pharmaceutical manufacturing and regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP knowledge, regulatory dossier assessment, deviation and complaint investigation, audit support, quality document review, continuous improvement, stakeholder collaboration
Preferred skills
Manufacturing environment familiarity, process improvement curiosity, independent task ownership
Technologies
GxP, QMS, MS Office
Responsibilities
Assess regulatory product dossiers and implement necessary changes; Handle and investigate deviations, complaints, and quality issues; Support and participate in audits and inspections; Review and approve quality documents (GxP / QMS); Support continuous improvement activities
Seniority
Mid-level, hands-on IC
