Drug Product Quality Assurance (3 years)-Reviewing Batch Records-Managing Product Changeover and conducting corresponding risk assessments-OOT/OOS (Out-of-Trend/Out-of-Specification) -SOPs (Standard Operating Procedures), Change Control, and DeviationProduct Release Quality Assurance (3 years)-QA Releasing and dispatching Drug Products to EU, US, Japan, and other regions-Managing communication with EU Qualified Persons and overseeing the issuance of QP certificates-Annual Product Quality Reports-Issuing Certificates of Analysis (CoAs) for Drug Products in compliance with regulatory approved specifications

Quality Compliance and Assurance 1. Supplier Qualification2. Internal Audit 3. Walk-through of GMP areas4. Regulatory Audit and External Audit Management and Coordination5. SOPs/Change Control/ Deviation review