Senior Auditor, Quality Assurance
Core
Conduct internal and contracted audits for the company and clients, lead complex audits, and provide QA consultancy within GxP expertise.
Role type
Senior Quality Assurance Auditor (Pharmaceutical/Biotech)
Builds
Audit reports, CAPA plans, SOPs, and quality gap analysis for clients and internal systems.
Domain
Pharmaceutical/Biotech Quality Management and Pharmacovigilance
Required skills
GxP expertise, GVP & GCP auditing, audit strategy planning, CAPA management, regulatory knowledge, SOP development, client communication
Preferred skills
Master's degree, local languages, strategic thinking
Technologies
GxP, GVP, GCP, QMS
Responsibilities
Conduct audits of partners, vendors, study files, and third parties; review and approve CAPA plans; perform gap analysis and SOP development; act as main QA contact for clients; support mock inspections and training; assist in regulatory inspections; develop audit strategy and train auditors.
Seniority
Senior, hands-on IC
