Mohit Malkani
Vice President of Engineering Services @Bioteknica, An Iqvia Business
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WORK HISTORY
Vice President of Engineering Services @Bioteknica, An Iqvia Business
Miami, TX, US
Provide advisory & consulting services focused on regulatory compliance to CFR 820, ISO13485, ISO14971. • Managed quality integration projects at multiple sites across the world. o Successfully implemented best-in-class validation practices. o Mentored site leaders and staff on various elements of the newly implemented quality management systems to initiate cultural change. o Provided coaching & mentoring various topics like validation, production & process controls, calibration to a diverse audience with different skill levels and language proficiencies.• Led a team of over 20 engineers to establish 3 new COVID test-kits manufacturing facilities.• Qualified and validated 2 new N95 masks facilities. Manage portfolio of Engineering service projects, engineering staff training and development, and expand quality engineering offerings beyond current emphasis on validations• Grow the Engineering services market with new offerings such as contract engineering in addition to current consulting services• Pursue a higher penetration of Florida based Medical Device and Pharmaceutical companies
EDUCATION
University of Illinois at Urbana-Champaign
Process Improvement
University of Massachusetts Lowell
MSE, Plastics
Savitribai Phule Pune University
BE, Chemical Engineering
International Management Institute - IMI
MBA, Internatiional Management
ABOUT MOHIT MALKANI
Mohit is a trained six-sigma black belt with 25+ years global leadership experience in the life sciences industry. Experienced in the establishment, integration, and remediation of Quality Management Systems (QMS) in a variety of domestic and international settings. Wide ranging functional expertise including process and test methods validations, production & process controls, risk management, project management and external audits. Experienced in outsourcing and transfer of manufacturing capacity. Experienced in organizational and staff development. Extensive experience with strategy, coordination, and management of an FDA-compliant world-class medical device manufacturing organization. Specialties: 21CFR 820, 21CFR Part 11, ISO 13485, ISO 14971; SME Process & Test Method Validations; Acquisition integration; Supplier selection (international & domestic); Outsourcing of capacity, Injection Molding validations, Team-Building, Coaching & Mentoring, Continuous Improvement.
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