Profile: Pharmaceutical Quality professional with 10 years’ experience in Analytical Method development and validations, Auditing, QMS, QRM, Regulatory Information Management Systems (RIMS) and CTD preparation and having knowledge and application of ICH Guidelines, DMF and GCPs principles. Skills include Analytical Method Development, Analytical Method Validation, incident, Deviations and Change Control, DMF and CTD preparation Auditing, Analytical results interpretation, Evaluation of Stability data, Document review of CFTs. , Team Management. Ok with ROW and India for audit service. Language expertise: English, Hindi and Telugu. Based in Hyderabad.