Ensure compliance with GMP, GDP, and local regulatory requirements.
Monitor implementation of Quality Management System (QMS).
Review SOPs and ensure they are updated according to regulatory standards.
Oversee management of Deviations, CAPA, Change Controls, and Risk Assessments.
Review and approve investigation reports and root cause analyses.
Ensure effective implementation and closure of CAPAs.
Monitor Data Integrity compliance (ALCOA++ principles).
Lead internal audits and participate in supplier audits.
Coordinate and manage responses to regulatory inspection findings.
Analyze compliance trends and recommend preventive strategies