Nayan Joshi Email & Phone Number

As a seasoned Pharma Professional with over 25 years of expertise, I excel in Software Qualification and Validation, Quality Control, Quality Assurance, and Lab Compliance. Currently leading a team in QMS & Documentation, I have a robust track record in FDA audits (USFDA, WHO, ANVISA, Indian FDA) and managing deviations, investigations, and CAPA.Key strengths include:• Development and qualification of Document Control Systems (DCS) in compliance with 21 CFR, cGMP, and regulatory standards.• Extensive experience in preparing SOPs, validation protocols, and technical specifications.• Proficiency in analyzing materials, managing stability studies, and ensuring regulatory compliance (FDA 21 CFR, EU Annex-11, ICH, PDA).• Skilled in instrument validation and operation (HPLC, FTIR, UV, etc.) and ensuring stringent quality measures.I am a decisive leader with a talent for organizing, motivating teams, and managing budgets to meet analytical, quality, and regulatory requirements effectively.