Senior Auditor, Quality Assurance (Pharmacovigilance Audit/GCP Audit experience required)
Core
Conduct internal and contracted audits for the company and clients, lead complex audits, and provide QA consultancy in GxP areas.
Role type
Senior Quality Assurance Auditor (Pharmacovigilance/GCP)
Builds
Audit reports, CAPA plans, SOPs, and quality gap analyses for biopharmaceutical clients.
Domain
Life Sciences / Pharmacovigilance / Quality Management Systems
Required skills
GxP auditing, pharmacovigilance, GVP, GCP, risk-based planning, CAPA management, SOP development, regulatory knowledge
Preferred skills
Master's degree, local languages, mock inspection experience
Technologies
GxP frameworks, QMS systems
Responsibilities
Conduct audits of partners, vendors, study files, and third parties; approve CAPA plans; perform gap analysis and SOP development; support mock inspections and training; develop audit strategy and procedures.
Seniority
Senior, hands-on IC
