Susmita Biswas

Background

About Susmita Biswas

9+ years of pharma industry experienced professional, currently in the role of System Manager for Lab IT cloud based system (NGS) typically involves overseeing the management, maintenance, and optimization of the system’s data, digital, and IT systems, basically E2E O&M if the system. This role combines elements of IT management, data governance, and digital technology oversight.• GxP Compliance: Extensive experience ensuring compliance with GxP standards, conducting audits, and overseeing quality control processes.• Regulatory Knowledge: Proficiency in regulations including GAPM5, CFR Part 11, Eudra-GMP, ICH Q7A, and MHRA Guidelines.• Process Optimization: Establishing efficient processes, SOPs, and work environments to enhance productivity and compliance.• Incident Management: Expertise in incident handling, deviation management, risk assessment, CAPA, RCA, and customer complaint resolution.• Quality Management: Leading SAP QM training, managing QMS operations, and overseeing system maintenance for continuous improvement.• Manufacturing Expertise: Technical lead in manufacturing, formulation, stability studies, and batch record design.• Leadership & Problem-Solving: Strong team leadership, analytical thinking, and adept problem-solving capabilities.