Kumar Dev Kushwah

I’m a microbiologist with 7.6 years of experience in Pharmaceutical Quality Control within regulated environments, supporting OSD and Parenteral manufacturing facilities. I manage complete microbiological laboratory operations, including water system monitoring, environmental monitoring, sterility support activities, and routine QC testing under GMP guidelines.

I strengthen quality systems through hands-on QMS documentation and compliance ownership. I manage Change Control end-to-end, prepare and update SOPs, perform risk assessments, and support laboratory investigations with root cause analysis and CAPA implementation. I also support audit and inspection readiness by providing required documentation and records, and I have exposure to EU GMP regulatory audits, along with audits in Ukraine, Kazakhstan, and Uzbekistan, plus self-inspection audits.

I improve lab effectiveness by working closely with IT and vendors on laboratory systems. I’ve supported LIMS implementation across Media, Culture, Environmental Monitoring, and Water modules, including master data setup, test configuration, and troubleshooting to ensure smooth operations. As a Training Coordinator for VLMS, I manage training activities, training matrices, training completion tracking, annual reconciliation, and audit-ready training documentation.

On the technical side, I contribute to validation and microbiological study execution in line with GMP expectations. I have performed Performance Qualification (PQ) of Purified Water systems and method development/validation for microbial enumeration testing, including media and hold time studies, swab sampling recovery, RODAC plate recovery, autoclave validation, and support for Computer System Validation (CSV). In daily laboratory work, I perform water sampling, microbial analysis, TOC testing, BET/endotoxin testing (including Endosafe Nexgen-PTS), bioburden testing, environmental monitoring, media preparation with GPT, MLT, and I operate core lab equipment while maintaining accurate documentation.