QA Compliance Specialist
Core
Ensures GxP compliance, audit readiness, and quality management for business operations, systems, and products to meet Novartis Quality Manual and regulatory standards.
Role type
QA Compliance Specialist (Pharmaceutical)
Builds
Quality management system compliance and audit readiness
Domain
Pharmaceutical manufacturing and quality assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP/GxP knowledge, deviation investigation, audit participation, validation documentation review, risk assessment, Lean Manufacturing, Six Sigma, MS Office proficiency, English communication
Preferred skills
None stated
Technologies
None stated
Responsibilities
Execute QA activities ensuring compliance with GMP, GxP, and internal procedures; Monitor quality-related activities including deviations and non-conformities; Participate in internal and external audits and inspections; Review and approve validation deliverables and GxP-impacting computerized system documentation; Support quality reporting, deviation investigations, and training; Lead Operational Excellence and Continuous Improvement initiatives using Lean and Six Sigma
Seniority
Mid-level, hands-on IC
