Ashwani Sharma
Quality Manager (Lead Consultant) @Infosys
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WORK HISTORY
Quality Manager (Lead Consultant) @Infosys
DE
Hexal Sandoz) Novartis at Holzkirchen, Bavaria
EDUCATION
Amity University
Bachelor of Technology - BTech, Computer Software Engineering
ABOUT ASHWANI SHARMA
Passionate about Healthcare industry by large and help companies how IT, Quality and Compliance can transform, provide benefits and accelerate business. Worked with US Pharma Major - Pfizer; Europe Pharma major - Astra Zeneca, Novartis & GSK, Indian Pharma Major - Sun Pharmaceuticals, Terapia.Currently working with Novartis, Germany. German language # B1 levelSpecialist in #Digital Healthcare #QMS #Quality audit #Software Implementation # Risk Management # IT Security #GDPR #Program Management #CSV #IT Quality #Data Integrity; extensive experience in FDA- GxP Predicate Rules, 21 CFR Part 11; EUDRALEX - Annex 11, GDPR, 13485, 21 CFR Part 820 regulations- Consulted a non-compliant company to be CSV compliant - Management of geographically-dispersed teams- Project planning, execution, and control- Pre-Sales - Internal & External auditsWorking/ Worked on large IT GxP project implementation- Automation of CSV Lifecycle ( HP Quality Center)- Full cycle ERP implementation (SAP, Oracle Lifesciences)- Trackwise Implementation- DevOps - Machine Learning and AI ( Artificial Intelligence)- IoT- Infrastructure qualification - AWS Cloud qualification- Water\'s suite for Analytical LabPersonal Interests : Astronomy & Stargazing, Yoga Teacher, Meditation practitioner, Martial arts fanatic, Motorcycling. Author of unpublished book on \'Aliens & UFOs\'(New) Learning Sailing from my wife and Bio-Food Farming
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