Ashutosh Kumar Bharti Email & Phone Number

Bengaluru, Karnataka, India

New Delhi Area, India

cGLP compliance ,Lab Compliance , Certified Administrator for Computerised system for validation and Implementation of QMS software's,DMS,LMS,LIMS etc.My responsibility includes selection of vendor for procurement / development of new Software's.e-compliance and monitoring.Perform Quality System reviews related to the System Life Cycle documentation and Change Control that ensures consistency to corporate and site policies for computer validation.Quality review and writing of Standard Operating Procedures, Qualification Protocols i.e. IQ, OQ, PQ and Global Templates for computer system validation as well and other GMP environment equipment/instruments.Ensure proper Risk assessment of software's to ensure the compliance of regulatory requirements.Periodic review and GAP assessment of critical GxP computerized systems to ensure the compliance of regulatory requirements.To Write guidelines, procedures, VMP,VP,PVP,URS/SRS ,GxP checklistand ,ER/ES checklist ,FRS, DS, IQ, OQ, PQ traceability matrix and Validation Summary Report and SRC.Provide technical support, regulations and standards support to the audit team for LIMS,LES,CSV ,LMS ,DMS ,SDMD and QMS

New Delhi Area, India

CSVC,GITP, IT Project (LMS,DMS,QAMS,LIMS)implementation and Quality compliance

Mumbai, Maharashtra, India

Ratlam Area, India

REPORTING TO AVP QUALITY

STABILITY INCHARGE

M.C.A.I.E In Analytical &Environmental Chemistry, Analytical Chemistry

Master In Industrial And Environmental Chemistry, Analytical And Pharmaceutical

Activities and Societies: TEAM LEADER AND ORGANISER