AQA - Data Reviewer

Role & responsibilities

• Ensure to comply the cGMP, GLP & GDP in laboratory
• Review the Inward logbook of sample received and analysis completion as per define time line.
• Knowledge of cGMPs, USP, and FDA (21 CFR Parts 210 and 211) regulations
• Verification the work allocation logbook of IP/ FP and HTS analysis with completion date
•  Responsible for reviewing of specification, Method of analysis, ATDS of finished, In-process and hold time study analytical documents.
• Verify the daily work allocation record which followed completely in QC lab
• Review analytical raw data to ensure ALCOA+ followed
• Knowledge into SAP system and QMS documentation
• Responsible to investigate the OOS/ OOT/ CAPA/ Notation and Deviation
• Ensure to compliance the testing as per defined Standard testing procedure. 
• Review the Hold time study protocol, report and analytical raw data with their logbook entries