Sumit Singh

Quality Control professional with 8+ years pharmaceutical industry experience, expert in Chromatographic technique, also GxP, and regulatory compliance. Responsible for comprehensive QC review, analysis, and documentation to meet strict industry & customer standards, with a strong record of improving quality and efficiency.

• Reviewed Electronic Record and audit trial generated from Chromeleon, Lab solution, and tiamo 2.5, Software etc.
• Ensured data integrity (ALCOA+) and 21 CFR Part 11 compliance for CDS and non-CDS laboratory instruments, including complete data reconciliation.
• Verified batch-wise test reports, instrument logbooks, and laboratory documentation as per current regulatory requirements.
• Conducted and supported OOS, OOT, and laboratory investigations, including CAPA implementation.
• Maintained and implemented QC SOPs, work instructions, and quality policies; supported continuous improvement initiatives.
• Monitored clean area compliance, safety practices, and online documentation to meet regulatory and GxP standards.
• Performed review and release activities for finished goods and process validation batches.
• Operated and supervised analytical instruments including HPLC, UV-Vis, Karl Fischer, Dissolution, Disintegration, pH meter, etc

• Analyzed of in-process samples, semi finish products and finished products as per current regulatory guidelines.
• Performed scheduled calibrations of weighing balance, pH meter, Karl Fisher.
• Conducted friability, hardness, weight variation, disintegration, content uniformity and uniformity of weight tests.
• Performed Raw material Sampling & Maintained sampling related records with current regulatory guanidine.
• Tested raw materials samples as per current Standard regulatory requirement & specifications.

• Chromeleon 6.8
• Empower 6.8
• Trackwise systems
• LMS
• Tiamo 2.5
• Lab solution
• Microsoft Word, Excel,Power Point

Name Sumit Singh

Father name Shri Vijay Singh

Date of Birth 20 July 1992

Village Dhakpura

Post Aung

District Mainpuri Uttar Pradesh 205262

I hereby declare that all statements made are true in the best of my knowledge and belief.