16+ Years of technical expertise
- With technical experience after working in large multinational company, AB has entrepreneurial skills to embody a unique benchmark, familiar with various approaches of achieving compliance.
- AB has a sound working knowledge of General Quality Management System (QMS), Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), electronic compliance & software, risk management and impact assessment.
- AB himself is a a CQI and IRCA certified lead QMS auditor and also a Certified Lead GxP Auditor with experience of conducting audits for third-party auditing agencies in located in the United States of America, United Kingdom, Germany, Spain, France, Italy, and Ireland.
- AB has extensive experience of conducting over 375 remote and on-site audits of manufacturing facilities in located in India, Europe, and other Asian countries and audited a diverse range of pharmaceutical products and components, including drug products (at clinical and commercial scale with small and higher batch sizes), Active Pharmaceutical ingredients (for clinical trials and at commercial scale of small and large batch sizes), key starting materials, intermediates, excipients, Packaging materials and medical devices in line with the required regulatory standards.
