Himanshu Darji

Background

About Himanshu Darji

To Prepare Validation Master Plan. To prepare Equipment, utility, process and other qualification Protocol & Report. Responsible for PV Execution and its compilation. To plan, monitor and execute validation activities as per VMP. Execution of Periodic re-qualification of various equipement like Autoclave, Tunnel, Washing machine, HVAC etc. Raise & Support the closure of Change Control Notes, and CAPA related to validation and qualification. To give compliance to CQA and audit. To conduct FAT for New equipments. To plan and conduct DQ, IQ, OQ and PQ of new equipment and instrument. Review of SOP of new equipement for smooth operation and preventive maintance of equipement. Review of Process validation, Cleaning validation protocol and report. To monitor calibration schedule. Review of calibration certificates. To plan, monitor and Execute Media Fill as per protocol To Perform Cleaning Validation of OSD Product & Parenteral Product Good hands over validation equipment like Kaye Validator, Kaye Valprobe, Data Loggers.