QA Expert Audits and Inspections 80-100%
Core
Coordinate and support regulatory inspections and customer audits for a sterile filling facility, ensuring smooth execution of audit activities and follow-up actions.
Role type
Senior Quality Assurance Audit Coordinator
Builds
Audit documentation, CAPA plans, and inspection readiness for sterile drug product manufacturing
Domain
Life Sciences / Pharmaceutical Manufacturing / GMP Compliance
Required skills
GMP principles, audit coordination, CAPA management, regulatory inspection support, sterile manufacturing knowledge, change control, deviation management
Preferred skills
Biologics/drug substance operations experience, German language proficiency
Technologies
TrackWise
Responsibilities
Coordinate regulatory inspections and customer audits, drive audit follow-up activities in TrackWise, contribute to inspection readiness initiatives, support GMP compliance and Quality Management System activities
Seniority
Mid-Senior, hands-on IC