Manager
CurrentProcess Development Lab - Introduced minimal validation of analytical methods. introduced calc. by Excel for Assay, residual solvents, related substances.Stability study reports recorded and shared electronically and eliminated paper.Eliminated ion-pair usage and reduced run time, process troubleshooting, material suitability & recovered solvent suitability test, lab batch monitoring and batch specification testing. calibration of instruments,stability study of lab batches, chemicals, spares, columns maintenance.Quality Assurance - Lead auditor, Approved Trainer, Approval of QC SOPs, investigation of OOS, Incidents, Deviations,CAPA, 21CFR Part 11 compliance, Forecast stability study, CSV, Temperature mapping of stability chambers, Mean Kinetic Temperature study, Qualification of equipment, Thermal cycle study, Holding time study, designing of Analytical raw data sheets, validation of spread sheets, change control initiation approval, specifications and testing procedures, customer and regulatory audits, support DMF preparation, support marketing and despatch. support License requirements, customer vendor qualification questionnaires, contract laboratory audits , Annual product quality review, continuous product quality review, Master calibration schedule, preventive maintenance approval. Approval of working standard, Approval QC protocol and reports. Trending of OOS, Incidents, Deviations, Stability data. Risk assessment elemental impurities&nitrosamine impurities, customer&RA queries. Analytical Development - R&D.IQ,OQ,PQ , Method Transfer sheet review, Testing procedures, specification, SOP,Incorporated Stability study extrapolation method through SOP & Training.Introduced SOP for SAP a new initiative & Training to execute. Audit trail compliance, cGMP and GLP compliance, AM Validation reviewCTD - Quality assuranceProduct development report, formulation, AMV, SOP, Biotech pilot plant, Anal.& Synthetic lab, compliance, Audit, Method Transfer, RA queries
