Bikram Singh Chauhan

About Bikram Singh Chauhan

With over two decades of diverse experience in pharmaceutical Quality Control, I bring a purpose-driven approach to ensuring regulatory compliance and operational excellence at Eugia Pharma Specialities Ltd. As Deputy General Manager, I lead a team of 76 dedicated professionals, overseeing laboratory operations, implementing robust quality systems, and ensuring alignment with 21 CFR Part 11 requirements. My focus on fostering innovation and collaboration enables our organization to consistently deliver high-quality injectable products while staying ahead of evolving regulatory expectations. At Eugia Pharma, I play a key role in laboratory setup, instrument qualification, and analytical method transfer, actively supporting critical product launches. My expertise encompasses stability studies, process validation, and effective management of laboratory incidents—ensuring smooth operations and a culture of continuous improvement. By integrating digital systems like eLIMS and driving efficient change management, I help sustain a quality-first mindset that supports long-term growth and compliance.

Experience

1. Deputy General Manager

   Eugia Pharma Specialities Ltd

   Nov 2021 — Present

   Working as Deputy General Manager- Quality Control Injectable(Liquid Vials, Ampoules, Cartage and Lyo) facility.Leading a team of 76 staff in QC and reports to AVP – Quality Head-> In my current role, responsible for Overall Quality Control along with Laboratory setup, instrument qualification, Exhibit stability studies, supporting product launching activities, analytical method transfer/verification, process validation, raw material, and finished product release, 21CFR part 11 compliance, change management system, LIMS, document review for compliance verification-> Deviations, change management, laboratory incidences, OOS, OOT, OOC, CAPA andQRM assessment-> Implemented eLIMS with instrument connectivity to eliminate the paperwork-> Implemented custom field calculation in Empower software-> Successfully set up the laboratory with lean approach and created paperless working environment with fully automation and instruments-> Successfully completed INFARMED (EU GMP) audit in February 2024-> Successfully completed USFDA audit in April 2024 and February 2025-> Successfully completed ANVISA audit in March 2025.

Education

• CCS (Chaudhary Charan Singh)University

  M.Sc.

  1998 — 2000