Officer Quality Assurance

Job Responsibilities • Preparation of Process validation protocol, Cleaning validation protocol and cleaning evaluation report, trending and establishment of LCL and UCL, APQRs and VMP supporting documents. • Preparation of Trending reports (Raw materials, Intermediates and Finished API) as per the schedule. • Re-evaluations, Temperature Mapping, Equipment change controls, DM water Validation, Environmental Monitoring, Calibration & Preventive Maintenance activities. • Preparation, Review of protocols and reports for Equipment, Support system qualification. • Execution and monitoring of Environmental monitoring Programs. • Execution and monitoring of Temperature mapping study. • Monitoring of Preventive Maintenance activities. • Review of the executed BPCR’s /GCR’s and Manufacturing related documentation support. • To ensure manufacturing documents are issued/archived as per procedure in line with manufacturing activities. • To monitor and ensure the Dispatch activities initiated after the Quality release. • Equipment and area clearance certification for product changeover.