NAGESH V KULKARNI

Deputy Manager

Biocon Biologics Limited

Bangalore

01.2012

Conducting analysis and collecting data to support the release of raw materials and in-process samples
Using analytical equipment like GC, HPLC, UV-Vis, FTNIR, IR, Titrations, USP Monograph Testing, Viscometer, Particle Size Analyzer and GPC properly
Working in accordance with approved methods, SOPs, cGMP's/GLPs while performing tests
Participating in Out of Specification investigations and writing analytical variances
Assisting with equipment qualification and ensuring instruments and equipment are being calibrated and kept in working order
Conducting lab/nonconformance investigations and special projects as assigned
Being involved in Computerized System Validation (CSV) using SAP
Working in a team to perform audits and develop corrective action plans
Being involved in testing and approving raw materials, qualifying equipment, and performing Computer System Validation
Actively working in a team environment, participating in natural work groups, and increasing productivity
Working closely with the QC lead/Manager as a team member, following an established test schedule
Preparing documents and technical reports for clients
Assisting with method implementation and/or method transfer and equipment qualification activities
Reducing testing on incoming raw materials through Kaizen Projects
Participating in discussions to identify opportunities for correction and improvement when scheduled work is not being achieved
Being certified in Lean Six Sigma, contributing to the efficiency and effectiveness of processes.

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