Conduct assigned external audits of contract manufacturers (CMOs), vendors, and suppliers, as well as occasional internal self-inspections of manufacturing processes and procedures
Job Summary
Conduct assigned external audits of contract manufacturers (CMOs), vendors, and suppliers, as well as occasional internal self-inspections of manufacturing processes and procedures.
Develop and issue comprehensive Audit Reports, categorizing findings by risk level and providing recommendations for corrective and preventive actions (CAPA).
Maintain up-to-date knowledge of global GMP regulations and industry trends, identifying new requirements to ensure a high level of quality is maintained internally.
Matching Summary
Conduct assigned external audits of contract manufacturers (CMOs), vendors, and suppliers, as well as occasional internal self-inspections of manufacturing processes and procedures.
Skills & Requirements
Must-have
GMP regulations knowledge
External audit execution
Internal audit execution
Risk categorization and reporting
Corrective action development
Nice-to-have
Collaborative stakeholder engagement
Systemic stability focus
Continuous improvement initiatives
Key Requirements
BS degree in biological science or related discipline
Quality Assurance experience in GMP-regulated environment
Audit and inspection management experience
Working knowledge of 21 CFR Parts 210/211, 600, 820 (ISO 13485), EudraLex Volume 4, Directive 2001/83/EC