Pratik Krishna

Background

About Pratik Krishna

Profile Summary: More than 12 years of rich experience in Quality Control in improving productivity of business and successfully implementing quality systems.>Exposure of audit in US FDA, TGA Australia, ANVISA Brazil, MCC South Africa, CDSCO India, RP Darmstadt Germany, Taiwan FDA, Uganda Regulatory and WHO.>Possess working exposures of API industries, Parenteral (LVP & SVP), Tablets, Capsules, Syrups, Ointments and Lozenges.>Expertise in Lab Compliance, LIMS & SAP management, Analytical data Review, GAP Assessment, Instrument Qualification, Software Qualification, CAPA, Change Control, Deviation, OOS/OOC and Lab incidents.>Deployed various methodologies for analyzing processes,recommending modifications to minimize escalations & rejection for realizing operational efficiencies, and control costs and cycle-time.*My Current Responsibility- 1)Section Head : GLP and QC Compliance. 2)To Supervise all QC activities as per Regulatory Guidelines and to ensure the QC Compliance adherence. 3)To ensure all analytical activities like Qualification, Calibration & GLP should proceed as per scheduled plan. 4)Proper Execution of OOS, OOT, Lab incident, Deviations and Change Control through Trackwise software and also give awareness training for avoidance of analytical error or repetitive errors to concerned personnel.*Technical & Documentation Skills - 1)Qualification of analytical instrument with software validation as per GAMP 5 Modules, 21 CFR (PART - 11), EDQM (Annex-3) and EU GMP (Annex-11) Compliance. 2)Caliber LIMS System Administrator in following companies like Unichem laboratories limited, SIKKIM, Fresenius Kabi Oncology ltd, Kalyani and LIVA PHARMACEUTICAL LIMITED, VADODARA. 3)Review and Analysis Experience skills in Raw Materials, Packing Materials, Intermediates, Bulk Finished Products, calibration records and stability samples records.*Certifications - 1)Classroom training in Global Labware LIMS program at Fresenius Kabi, Oberursel, Germany. 2) Approved Technical Staff by FDA, MAHARASHTRA in Chemical and Instrumentation section in 2018. 3) Approved Chemist in Quality Control by Deptt. of Healthcare Human Services & Family Warfare,Sikkim.