Kalpesh Halware

Background

About Kalpesh Halware

To prepare and review Impact / Risk assessment, URS, DQ, FAT, SAT, IQ, OQ, PQ protocols for process equipment / instrument for UTILITY, OSD and INJECTABLE. To review qualification / validation documents with respect to computerizes system ( PLC/SCADA/HMI ). To prepare, execution and summarization of report with respect to compressed air validation,pure steam validation and nitrogen gas validation. To ensure periodic performance verification for equipment’s and utilities. To handle personnel qualification activities.(Visual inspector qualification certificate) To review vendor data. To fill qualification reports. To handle temperature mapping activity. To ensure line clearance activity for Dispensing,Manufacturing,Filtration,Filling,Sterilization and Packing of OSD & INJ. Review of BMR & BPR. To verify the Environmental monitoring data of the clean area. To verify online documentation (Batch records,logbook etc.) To handle any work allocated by manager-QA as and when required.