Reviewed batch records from CMO operations to ensure that the records meet cGMP requirements; Collect temperature data loggers and prepare temperature analysis report; Release or reject products. Oversaw review and approval of labeling and drug facts for new and existing products. Drafted SOP and packaging specification; Manage change control; Archive documents and records.Assisted departmental supervisors with investigations related to product quality, identifying errors and solving problems in collaboration with external manufacturers.

Managed international cooperation project with oversight of EU GMP certification inspection, foreign client audits, and provided support for internal and external audits.Supervised, planned training programs and significantly improved work performance of subordinates.Led purchase of equipment and instruments, instrument calibration and equipment re-qualificationDeveloped validation plan and summary report; prepared SOP and provided leadership for OOS, Deviation, CAPA, and change control and all deviation reports during validation and qualification process, preparation of test method validation protocol and summary report.Planned for water system monitoring and supported the water system qualification for WFI, purified water and clean steam; provided support for process validation including media fill.Received the Junior Manager Silver Award in 2013.

Oversaw routine analysis of raw materials and finished products in QC lab using Electronic Balance, KF Titrator, FTIR, UV-Vis Spectrometry, and HPLC; plus sterility test and microbial limit test.Prepared and introduced SOP, validation and qualification protocols in QC lab; managed instrument calibration and equipment re-qualification.Responder to questions from inspector during site inspection for EU GMP certification inspection of production of oral solid dosage and sterile products.