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
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.