Naga Valli Chetty

Worked in development, validation, production and preproduction.

Designed and implemented LIMS master data.

Suggested and executed enhancement for lab systems to achieve laboratory objectives.

Deployment of various instruments.

Responsible in analyzing the issues and query in LIMS

Operations and usage of accessories for LIMS, Instrument interface with LIMS, Inventory management in LIMS, Investigation management in LIMS.

Prepared and executed test scripts

Have Good understanding/knowledge of Pharma Regulatory requirements including 21 CFR Part 11, EU Annex 11, GAMP 5 guidelines & Good Documentation Practices.

Handling of Laboratory Investigations and CAPA via TrackWise system.

Change Control related to lab and LIMS activities using e-QMS (TrackWise)

Worked with vendors and other support teams to prioritize, escalate as necessary, and resolved identified technical issues

Communicated issues and status to internal user community

Contributed subject matter expertise during root cause analysis and problem solving activities during system outages.

Experience in Labware/LabVantage migration methodology and execution.

Wide knowledgeable of FDA cGMP/GLP and related regulations.

Hands on experience in configuration, customization and deployment of LabVantage LIMS.

Configuring Sample Plan, Item Code, Analysis and Product according to the specification documents received from customers for different product types like Raw Material, Drug Substance and In Process etc.

Administrative activities to create and modify LIMS user accounts, assigning new roles, role modification to provide reliable service to all the users

Ensured regulatory compliance with FDA, EPA, and ISO guidelines through strict adherence to protocols and proper documentation.

Supported facility audits by providing comprehensive documentation of microbiological tests and results.