MSc , MBA and total 24 years experience of highly regulated environment US/EU and International Laboratory establishment exposure.LIMS execution exposure at various units.Skill for Audit Mgt. of USFDA/MHRA/EU/ANVISA etc.Exposure of Quality system for new site projection , Conceptual designing ,development and updating for regulated market. Lead a team who are responsible to analyse and release incoming Materials to finished product with 24 X 7 cGLP Compliance environment.Audit Mgt.(Internal & External Audits). USFDA,EU,MHRA,ANVISA,MCA, TGA,WHO audit exposure etc. Exposure of Analytical Method Transfer, Verification and covalidation activities to EU and other Countries.Exposure of handling CRF,OOT,OOS,OOC, Incident, Deviation etc. Exposure of Quality Culure, QbD and Quality mindset.Exposure of CSV, Water system qualification.Monitoring activities of Instrument Technical Recommondation to Qualification, Calibration, AMC etc. Budget Activities (CAPEX,Revenue and Manpower)Exposure of fully 21 CFR part 11 Compliance and EU annexure XI requirements for Waters,Dionex, Shimadzu and Agilent Softwares. (Electronic Signature and Auto Calculation) Computer System validation as per GAMP5. Effective Documentation activities. Monitoring SOP preparation and Training (Internal & External) Activities to upgrade staff technical competency. Exposure of ISO17025 accreditation & also work as dy. Quality Mgr.,Technical Mgr.

MSc , MBA and experience of highly regulated environment US/EU and International Laboratory establishment exposure (Project exposure at EU Country , Heumann Pharma , Germany and TDBL, Sao Paulo, Brazil ). Skill for Audit Mgt. of USFDA/MHRA/EU/ANVISA etc.Lead a team who monitoring 24 X 7 cGLP Compliance of Formualtion , API and Stability Lab. Audit Mgt.(Internal & External Audits). USFDA,EU,MHRA,ANVISA,MCA, TGA,WHO audit exposure etc. Resposible for Analytical Method Transfer, Verification and covalidation activities to EU and other Countries.Exposure of handling CRF,OOT,OOS,OOC, Incident, Deviation etc. Monitoring activities of Instrument Technical Recommondation to Qualification, Calibration, AMC etc. Budget Activities (CAPEX,Revenue and Manpower)Exposure of new site projection , Conceptual designing ,development and updating for regulated Market environment. Exposure of fully 21 CFR part 11 Compliance and EU annexure XI requirements for Waters,Dionex, Shimadzu and Agilent Softwares. (Electronic Signature and Auto Calculation) Excelsheet validation as per GAMP5. Effective Documentation activities. Reference/Working Standard Mgt. Monitoring SOP preparation and Training (Internal & External) Activities to upgrade staff technical competency. Exposure of ISO17025 accreditation & also work as dy. Quality Mgr.,Technical Mgr.