Praviin Kulkarni Email & Phone Number

- Highly experienced Validation consultant with a proven record of 20 years of experience executing, leading & managing Pharmaceutical & Healthcare projects in Australia, Netherlands and India.- An inquisitive professional with thorough knowledge and experience in implementation & integration of Information Systems, automation and process control systems & processes used in Pharmaceutical & Healthcare sectors viz. Clinical Trial Systems, Hospital Management System, Laboratory Information Management System (LIMS) and Manufacturing Execution System (MES). Have managed project concerning SAP, Infrastructure management, system integration, Computer System Validation, QMS, GAMP5, 21CFR Part 11, Annex 11, Information Security management & ITIL processes implementation. - Experienced in facing and leading regulatory audits viz. TGA, USFDA, WHO, EU by providing necessary support to QA, QC & Production & Clinical departments for their continued regulatory compliance.- Implemented, Delivered & Managed Business Technology and process automation software & Infrastructure projects in Pharmaceutical manufacturing domain through skills in Resource planning, Budgeting, SLA Management, vendor management, system availability, system integration, risk analysis, compliance & security.- Designed & implemented fail safe Disaster Recovery Management solutions for the enterprise ensuring 99.97% uptime of SAP, LIMS, SCADA, various applications & other data center and control system components.- PMP Certified with expertise in handling various large Business Technology Infrastructure, automation systems & Application projects in Pharmaceutical manufacturing and QC systems worth $5M in accordance with principles of PMBOK. Possesses exceptional Stakeholder engagement & communication skills.- Individual contributor and great team player; flexible, quick learner; self-motivated

Listed skills include Information Security Management, Project Management, Biotechnology, Microsoft Office, and 42 others.