Somyadeep Biswal

Quality Control with 4+ years of experience in aseptic injectable manufacturing and biologics, ensuring compliance with GMP, GLP, and SOP standards. Proven expertise in executing ELISA-based assays, and analytical method validation for plasma-derived drug substances and products. Skilled in operating and maintaining sophisticated laboratory instruments to support quality systems, documentation, and regulatory compliance in pharmaceutical operations.

Quality Control Executive - Ichor Biologics Pvt Ltd

(2024-12)

• Executing quality control analysis for aseptic injectable plasma-derived products, including Immunoglobulin, Albumin, in compliance with GMP and GLP standards.
• Handling In-Process, Drug Substance, Drug Product, and Stability samples, ensuring adherence to approved procedures and documentation protocols.
• Operating and calibrating key laboratory instruments such as UV-Visible Spectrophotometer, Osmometer, and pH Meter to maintain data integrity.
• Performing ELISA-based testing for Viral Markers, Immunoglobulin A, IgG Subclasses, and Pre-Kallikrein Activator, contributing to product safety and compliance.
• Actively participating in Analytical Method Validation activities and ensuring strict compliance with GLP, GDP, SOP, and GMP guidelines.

Quality Control Executive - Virchow Biotech Pvt Ltd

(2022-01 - 2024-12)

• Conducted routine and stability testing of biologics and pharmaceutical products, supporting product release and shelf-life determination.
• Performed protein estimation using multiple validated methods (OD at 280 nm, Biuret, Lowry) to ensure accurate quantification.
• Executed ELISA techniques for qualitative and quantitative analysis, contributing to method validation and sample testing.
• Prepared and documented reagents, standards, and calibration solutions in strict accordance with SOPs, maintaining laboratory compliance.
• Maintained laboratory operations in full compliance with GLP, GDP, and regulatory standards, supporting audit readiness.
• Supported validation and qualification activities for laboratory methods and equipment, enhancing operational reliability.

Bachelor of Science - Utkal University BBSR

Intermediate - ITER SOA University

Master of Science - GIET University gunupur