Manojkumar Suru

Background

About Manojkumar Suru

I am a Development Analyst with 6+ years of experience in pharmaceutical analysis, quality control, and method validation within cGMP, FDA, and MHRA-regulated environments. My expertise includes HPLC, Gas Chromatography (GC), Dissolution Testing, Karl Fischer, and Stability Studies, ensuring product quality and regulatory compliance. I specialize in analytical method validation and transfer for OSD & API, supporting formulation development and impurity profiling. I have a strong background in data reporting, troubleshooting analytical challenges, and cross-functional collaboration while maintaining ICH Q2 regulatory compliance. Passionate about pharmaceutical quality and process optimization, I excel in technical report writing, root cause analysis, and regulatory submissions. I thrive in high-pressure environments, bringing a solution-driven approach to analytical challenges. Key Skills: Method Development & Validation (HPLC, GC, Dissolution, Karl Fischer) Stability Studies & Impurity Profiling Regulatory Compliance (cGMP, FDA, MHRA, ICH Q2) Troubleshooting & Root Cause Analysis Cross-functional Collaboration & Team Leadership I am always open to networking and discussing opportunities in analytical development, QC, and regulatory affairs. Let’s connect!