QA Compliance Specialist
Core
Strengthen the site's Quality Management System (QMS) and support compliance with GMP, regulatory requirements, and Lonza Global Quality Standards.
Role type
QA Compliance Specialist
Builds
High-quality medicines and services
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
dashboards & analysis
Required skills
GMP principles, Quality Management Systems, quality compliance requirements, deviation management, CAPA management, change control, risk assessment, supplier qualification, audit support, training delivery, continuous improvement
Preferred skills
SAP proficiency, document management systems, learning management systems, GMP-regulated environment experience
Responsibilities
Support quality documentation, training administration, and quality records; Review and manage deviations, CAPAs, change controls, and risk assessments; Coordinate supplier and service provider qualification activities; Support internal, customer, and external audits and regulatory inspections; Deliver GMP and compliance-related training; Identify opportunities to improve quality systems and compliance processes
Seniority
Individual Contributor
