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Pratin Sharma

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A proven professional in the pharmaceutical industry having safety-driven, goal-oriented mindset with around 11+ Years of experience in Validation and Quality Assurance. I’m seeking a challenging opportunity to manage or lead large projects where my advanced skills, education, extensive training, and many years of experience can be fully utilized. A versatile professional with entrepreneurship mind-set, accountability, agility, and focus on overcoming obstacles, actions, implementation & continuous improvement. Strong analytical skills, ability to think and act strategically with exceptional focus and prioritization. Demonstrated project leadership, managing complex workstreams and large teams of cross-functional colleagues with varying backgrounds and skillsets. Demonstrated ability and experience in overseeing the day-to-day work of fellow colleagues and subordinates, including providing coaching, mentorship, and development. Ability to work effectively in a matrix organization and lead with indirect authority. An effective communicator and motivator with skills to sustain work environment towards accomplishment of organizational goals. Handled the US FDA, WHO, and local regulatory inspections for Biological, vaccine and sterile injectables. A person having sound knowledge of GMP facility requirements for Sterile (Small volume Fill finish), Biological and vaccine products. Green field project setup for sterile pharma, vaccine and biotech companies. Validation and Qualification expert for all types of parenteral pharmaceutical, vaccine and Bio-pharmaceutical equipment, utilities including computer system validation. Air flow visualization expertise. My core expertise areas are; - ITQA-CSV - Process Equipment Qualification & Validation - Pharmaceutical Quality Management System - Cleaning Validation

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