I will audit pharmaceutical and biotech operations

  PROFILE SUMMARY Pharmaceutical & Biotech Operations Leader with wealth of experience in large-scale vaccine manufacturing, covering formulation, filling, packing, and bulk antigen production. As a Senior Manager at GCBC Vaccines Pvt. Ltd., managed end-to-end operations across formulation, filling, packing, laundry, commercial functions, and GMP adherence across production blocks. Broad vaccine expertise across Diphtheria, Pertussis, Tetanus, Hepatitis B, Hib, and Cholera with strong proficiency in GMP, aseptic operations, equipment qualification, process optimization, and quality systems. Regulatory and audit specialist, leading WHO, CDL, ISO, and global internal inspections, ensuring compliance with international and Indian standards and maintaining robust documentation (BMRs, SOPs, RSTs). Effective people leader, managing personnel across multiple suites with strengths in manpower planning, GMP training, performance oversight, and building high-performance teams. SAP (ERP) and QMS expert, acting as a nuclear team member for SAP implementation, optimizing manufacturing modules, managing CAPA, failure investigations, and ensuring regulatory-compliant quality systems. Strong proje