Job Description

Responsibilities

Review and approve GMP documentation and batch records to ensure accuracy and compliance with standards
Manage deviations, CAPA, change controls, and customer complaints to resolve quality issues effectively
Conduct GMP training sessions and internal audits to maintain staff competency and system integrity
Support regulatory inspections and external audits by preparing documentation and facilitating processes
Maintain document control and quality systems to ensure up-to-date and accessible records
Perform supplier qualification and conduct quality risk assessments to ensure supplier reliability
Support validation and qualification activities to verify process and equipment compliance
Prepare Annual Product Reviews and analyze quality trends to identify improvement opportunities
Ensure ongoing compliance with GMP, regulatory, and company requirements to uphold product quality