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- Managed new product releases while ensuring timely completion of milestones.- Led investigations into complaints, process defects by identifying root causes and implementing correctiveactions to prevent recurrence.- Resolved process defects through managing quality documents and streamlining production.

Quality Assurance- Improved Data Integrity by setting up GMP IT system process (EDMS, QMS).- Conducted GMP, QMS training for Quality and Manufacturing departments, resulting in reducing deviations 5%- Managed Quality documents - SOPs, Master Formula, Drawings, and etc.- Developed and implemented procedure for QMS, resulting in 10% reduction in deviations.- Conducted Audits from MFDS and global pharmaceutical companies to ensure compliance with regulatory requirements.-… Show more Quality Assurance- Improved Data Integrity by setting up GMP IT system process (EDMS, QMS).- Conducted GMP, QMS training for Quality and Manufacturing departments, resulting in reducing deviations 5%- Managed Quality documents - SOPs, Master Formula, Drawings, and etc.- Developed and implemented procedure for QMS, resulting in 10% reduction in deviations.- Conducted Audits from MFDS and global pharmaceutical companies to ensure compliance with regulatory requirements.- Conducted Vendor audits for calibration to ensure equipment accuracy and compliances with regulatory requirements.- Managed Change Control Projects for equipment, regulations, and test methods, reducing deviations by 10%Quality Control - Managed maintenance and Calibration of Test equipment, reduced calibration cost approximately 10% off. - Developed Test methods according to USP, conducted Method Validation to ensure accuracy and precision of test results. - Performed quality test for final product to guarantee quality compliance with regulatory requirements. - Experienced in virology tests, including quantity, identification, and adventitious virus testing. - Conducted validations of PQ, CSV, and gowning Performed Validation of PQ, CSV, and gowning validation. Show less