Ajay Babu Pazhayattil
Management Consultant @Cgmp World
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WORK HISTORY
Management Consultant @Cgmp World
CA
Global Clientele- Leading US FDA consulting firm (Washington, DC, USA)- A leading global generic pharmaceutical company (Hyderabad, TG, India)- One of the largest API manufacturers with >250 molecules across various therapeutic categories (Hyderabad, TG, India)- Major solid oral and injectable (general and onco) generic pharmaceutical company (Ahmedabad, GJ, India)- Prominent injectable CDMO (Baltimore and Rockville, MD, USA)- Leading CGT media manufacturing company (Grand Island, NY, USA)- Largest validation SaaS provider (San Francisco, CA, USA)- Key injectable generic manufacturer (Hyderabad, TG, India)- Major injectable CDMO (Nashville, TN, USA)#Process #Validation #Quality & Compliance #Aseptic #TechnologyTranfer #Expertise #LeadershipKey Contributions:• Led science-driven process remediation to resolve QbD development, technology transfer gaps and inter/intra-batch variability issues (Process Validation) cited in US FDA warning letters for solid oral and injectable facilities (general and oncology). Designed strategic, statistically robust solutions to restore compliance and ensure long-term regulatory alignment.• Served as Aseptic Oversight SME, driving remediation of aseptic practices and personnel behaviors in response to FDA warning letters. Provided oversight for biopharma vial and syringe lines using RABS and isolator technologies.• Conceptualized a Master Validation Plan to support science- and data-driven decision-making, ensuring compliance with ATMP and CGT regulatory frameworks.• Spearheaded the establishment of Validation and Metrology groups, overseeing the commissioning and qualification of new vial, syringe, and bag-filling lines as part of facility expansion projects.
EDUCATION
California Southern University
Doctor of Philosophy - PhD, Business Administration, Management and Operations
Rajiv Gandhi University of Health Sciences
Master of Pharmacy - MPharm, Pharmaceutical Chemistry
Mangalore University
Bachelor of Pharmacy - BPharm, Pharmacy
ABOUT AJAY BABU PAZHAYATTIL
I help pharmaceutical companies resolve FDA Warning Letters, respond to FDA inspections, and execute GMP remediation when failures in pharmaceutical quality systems and process validation create regulatory, compliance, and supply-chain risk.With 25+ years of pharmaceutical quality, GMP compliance, and regulatory experience, my work focuses on FDA Warning Letter remediation, FDA inspection readiness, and process validation (Stage 1, Stage 2, Stage 3) across solid oral dosage forms, sterile injectables, aseptic manufacturing, biologics, CGT, and mRNA manufacturing facilities.I have led FDA remediation programs addressing Form 483 observations related to process validation deficiencies, continued process verification (CPV) failures, aseptic manufacturing practices, data integrity, and ineffective pharmaceutical quality system (PQS) governance, resulting in successful FDA reinspections, restored GMP compliance, and sustained regulatory confidence.My experience spans senior executive leadership and hands-on consulting roles supporting FDA inspections, GMP remediation, technology transfer, process validation remediation, and pharmaceutical quality system transformation for global pharmaceutical manufacturers across North America and India.I am an author and industry authority on pharmaceutical quality systems, FDA compliance, process validation, and continued process verification, with widely cited publications focused on lifecycle validation, modern GMP expectations, and regulatory enforcement trends.Primary Expertise:• FDA Warning Letter remediation• FDA inspections & Form 483 response• GMP compliance & GMP remediation• Process Validation (Stage 1, Stage 2, Stage 3)• Continued Process Verification (CPV Stage 3)• Pharmaceutical Quality Systems (PQS)• Aseptic manufacturing (RABS & isolators)• Technology transfer & validation remediationIf your organization is facing FDA Warning Letters, FDA inspection risk, process validation failures, or GMP compliance gaps, I partner with leadership teams to restore regulatory control and long-term pharmaceutical quality system effectiveness.
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