Shivaraj Kumar K M

Associate at AstraZeneca Pharma India Pvt Limited

• India - Bengaluru
• My current job since March 2015

• Successfully faced Regulatory audits US FDA, WHO and TGA, Customer audits GSK, Merck, Sun pharma and Hospira.
• Performing Technology transfer studies, stability studies and Investigation analysis.
• Handled instruments like HPLC, GC, UV, IR, ICP-OES, AAS and Autotitrator.
• Worked for Empower-3 software updating and CSVC Validation Activities.
• Worked for Water content EP Suitability Analysis
• Worked for Stability and Stability Chamber Management activities.
• Trending of Stability results and its compilation.
• Review of Analytical data.
• Preparation of Technology transfer, Collaborative Validation and Method verification report.
• EP suitability of water content and Audit document review.