Quality Auditor
Core
Manage on-site audits and quality assessments for suppliers and third-party manufacturers to ensure compliance, quality, and regulatory adherence for Abbott's Established Pharmaceuticals Division.
Role type
Senior Quality Auditor (Supplier/Third-Party Oversight)
Builds
Supplier quality compliance and regulatory adherence for external partner network
Domain
Pharmaceutical manufacturing and supply chain
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP auditing, CAPA management, regulatory compliance analysis, supplier assessment, risk identification, technical writing
Preferred skills
Knowledge of ICH guidelines, WHO guidance, regional/local regulations, international travel
Technologies
Audit Tracking system
Responsibilities
Plan, prepare, conduct, report, and close on-site audits; Manage Quality Questionnaires and resolve issues; Assess and track Corrective and Preventive Actions (CAPAs); Monitor regulatory developments and integrate into audit activities; Support manufacturing sites in resolving supplier-related quality issues; Act as primary quality contact for external partners.