GMP Compliance Auditor (m/w/d)
Core
Independently plan and conduct internal system audits and external GxP supplier audits for pharmaceutical products, medical devices, and regulated studies.
Role type
Senior GMP Compliance Auditor
Builds
Approved supplier lists, global audit schedules, and quality trend analysis reports
Domain
Pharmaceutical / Medical Device / Healthcare Industry
Required skills
GMP regulatory standards interpretation, internal system auditing, external supplier auditing, supplier management, quality metrics analysis, regulatory compliance issue resolution, GxP training and guidance, procedural documentation
Preferred skills
Quality Assurance auditing, Laboratory experience, ASQ CQM/CQA certification
Technologies
GxP regulations, GVP-Tarifvertrag
Responsibilities
Interpret and apply current regulations for pharmaceutical products and medical devices, maintain approved supplier list and global audit schedule, gather and present audit metrics for trend analysis, recommend action plans for quality issues, provide guidance on GxP regulations, assist QA Management with external regulatory audits, develop and update departmental systems and procedures
Seniority
Senior, hands-on IC
