Audit and Supplier Qualification Specialist
Core
Manage supplier audits, qualifications, and compliance within a pharmaceutical manufacturing environment to ensure cGMP adherence.
Role type
Quality Assurance Specialist (Supplier Management & Auditing)
Builds
Supplier qualification programs and audit reports
Domain
Biopharma / Pharmaceutical Manufacturing
Required skills
Supplier management, auditing, cGMP knowledge, regulatory compliance, deviation management, SOP generation, quality systems
Preferred skills
Lead auditor qualification, 3-5 years supplier management experience, Eudralex Volume 4 knowledge, ISO 13485 knowledge
Technologies
MasterControl
Responsibilities
Conduct and host supplier audits, prepare qualification templates (QTA), raise deviations and corrective action requests, generate SOPs and forms, support regulatory audits, ensure safe work practices and report near misses.
Seniority
Mid-level, hands-on IC
