03.09.2025 aktualisiert


Premiumkunde
100 % verfügbarFreelance GMP auditor and Pharmaceutical Consultant
Ahmedabad, Indien
Weltweit
Master in PharmacySkills
I am Adish Bhatnagar from India and a I am a freelance technical service provider for GMP audits and Pharmaceutical consultation.
• I have 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.
• I am a Certified Lead GxP Auditor with experience conducting audits for third-party auditing agencies in India, USA, United Kingdom, Germany, Spain, France, Italy, and Ireland.
• I have extensive experience of conducting over 400 remote and on-site audits of manufacturing facilities in located in Europe, India and other Asian countries.
• My audits evaluate compliance with ISO standards and regulatory requirements, including Schedule M (India), ICH Q7, EudraLex, USFDA 21 CFR, and other applicable regulatory standards.
• I have audited a diverse range of products and materials, including drug products (clinical and commercial), Active Pharmaceutical ingredients (clinical trial and commercial), key starting materials, intermediates, excipients, Packaging materials and medical devices.
• Preparing detailed reports summarizing findings and areas for improvement.
• My expertise spans the complete material management, manufacturing process, quality management system, general quality control system, utilities and good distribution practices.
• I have 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.
• I am a Certified Lead GxP Auditor with experience conducting audits for third-party auditing agencies in India, USA, United Kingdom, Germany, Spain, France, Italy, and Ireland.
• I have extensive experience of conducting over 400 remote and on-site audits of manufacturing facilities in located in Europe, India and other Asian countries.
• My audits evaluate compliance with ISO standards and regulatory requirements, including Schedule M (India), ICH Q7, EudraLex, USFDA 21 CFR, and other applicable regulatory standards.
• I have audited a diverse range of products and materials, including drug products (clinical and commercial), Active Pharmaceutical ingredients (clinical trial and commercial), key starting materials, intermediates, excipients, Packaging materials and medical devices.
• Preparing detailed reports summarizing findings and areas for improvement.
• My expertise spans the complete material management, manufacturing process, quality management system, general quality control system, utilities and good distribution practices.
Sprachen
EnglishverhandlungssicherHindiMuttersprache
Zertifikate
ISO 13485:2016
British Standard Institute BSI2023
ISO 9001:2015 Lead Auditor
British Standard Institute BSI2021