Kiki Stein
Digital Transformation Validation Expert, CSV Lead, CSA Lead, SAP Testing Functional Lead, Quality and Regulatory GxP Expert, Pharma 4.0 Digital Validation Expert, QMS Expert - Life Sciences
- Role
- Computer Systems Validation Lead Consultant - Senior Consultant at Clarkston Consulting
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
About Kiki Stein
Global Computer Systems Validation, Regulatory, and Quality Compliance Expert with over…
Experience
Computer Systems Validation Lead Consultant - Senior Consultant
Oct 2020 — Present · Naples, FL, US
Business across the consumer products, retail and life sciences industries partner with Clarkston Consulting to enhance strategic decision-making, improve operational efficiencies, implement new technologies, and promote business growth and market diversification. Leveraging deep functional and industry expertise, our people discover, design, and deliver solutions that fit your business, your goals, and your future. At Clarkston, your purpose is our purpose.
Education
Alma Mater Studiorum – Università di Bologna
B.S
Skills
- Quality Assurance
- V
- Wireless
- Business Analysis
- Cross-Functional Team Leadership
- R
- Product Management
- Requirements Analysis
- Validation
- Testing
- 21 Cfr Part 11
- Process Improvement
- Design Control
- Six Sigma
- Product Launch
- Test Planning
- Change Management
- Healthcare
- Software Quality Assurance
- Regulatory Affairs
- Quality System
- Process Simulation
- Iso
- Fda
- Quality Management
- Telecommunications
- Product Development
- Gmp
- Design of Experiments
- Manufacturing
- Medical Devices
- Capa
- Agile Methodologies
- Iso 13485
- Management
- Test Automation
- Software Documentation
- Sdlc
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