Basika Prashanth Kumar

Background

About Basika Prashanth Kumar

Quality (QA/QC) and Validation Professional with over 20 years of expertise in cGxP across Biologics and ATMPs (Cell & Gene Therapy industries). Key experience include- Successfully directed and established QA, Validation strategies and Quality Management Systems (QMS) from the very beginning in multiple startups- Site Leadership Team member in multiple startup environments- Extensive experience in QA/QC operations, Technology Transfer, validation processes, and cGxP compliance- Proficient in microbiology lab operations, including environmental monitoring- Experienced in GLP lab setup, laboratory software implementation (CSV compliance with 21 CFR Part 11), and laboratory equipment qualifications- Proficient with Labware LIMS, Thermo LIMS Sample Manager, Trackwise, DocLink, LiveLink, Documentum, and SAP etc- Strong people management and project management skills- Direct exposure to audits by USFDA, EMA, and HSA. Skill Set: Quality Control, Quality Assurance, cGxP, LEQ (Laboratory Equipment Qualification). CSV (Computer System Validation), Validation of Facilities/Utilities/Equipment, Shipping (Cold Chain Management) Validation, Aseptic Handling, Microbiology & EM Lab Operations, CR, Deviation Management, CAPA, RA, CIP, SIP, Clean Room Operations, Calibration, Sample Management, Warehouse Management, Training, Quick Learning, Adopt to changes, Continuous Improvement Projects, Sourcing & Inventory Management, Safety, Leadership, People Management and Task Scheduling, Problem solving and Troubleshooting.