Maheswara Nalinikanth Email & Phone Number

Expertise in handling Qualifications, Validations, Technology Transfer, Change controls, OOS, Deviations, Incidents, Product Complaints, APQR, investigations and CAPA. Planning systems and procedures to achieve complete data integrity compliance of electronic and paper based recordsConducting validations, quality audits and defining facility up-gradation to meet the requirements of regulatory marketMonitoring drug substance quality trends and CpK evaluation. Reviewing and approving SOP’s, technical specifications, batch production record, validation protocols, validation reports and other quality documents Validating analytical systems i.e. rigorous testing of the methods to ensure that they are precise, accurate, reproducible & specific to the productQualification of process and utility equipment, HVAC & Purified Water System validationsVendor evaluation, audits and risk assessment.

Listed skills include Capa, Validation, Quality System, Gmp, and 9 others.