Ensure effective implementation and maintenance of the site PQS/QMS.
Monitor compliance with approved SOPs, policies, GMP requirements and quality standards.
Ensure adequate systems for deviations, investigations, CAPA, change controls, OOS/OOT, incidents and quality risk management.
Review quality-system trends and identify opportunities for continual improvement.
Ensure quality-system actions are completed within established timelines.
Quality management, CAPA, change management, process/product monitoring and management review are core elements of the ICH Q10 framework