Shamara Karunaratne
Project Manager, Change Management at Eisai
- Role
- Project Manager, Change Management at Eisai US
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Shamara Karunaratne
I am a highly motivated Biotechnology professional with 10+ years of experience in Process Analytics, Manufacturing Sciences and Quality Engineering.Colleagues would describe me as a reliable and self-motivated individual with exceptional attention to detail. Any team that I\'m a part of can depend on me to complete any task assigned to me on time without compromising on quality or compliance. I enjoy taking on tasks and pursuing opportunities that leverage my background in Process Analytics, Manufacturing Sciences and Quality Engineering. Specialties: Change Management, FUME Compliance, Process Monitoring, Data Management, Statistics, Quality Engineering, Process Validation, Cleaning Validation, Root-Cause Analysis and Software (Agile PLM, TrackWise, Infor CMMS, Discoverant, SIMCA Online, DeltaV, OSIsoft PI).
Experience
Project Manager, Change Management
Apr 2025 — Present · Raleigh, NC, US
Managing Evaluation of Product Changes through the Quality Change Management Process• Collaborating with Global Regulatory Teams on Assessments and Documentation for Product Approvals, Renewals, and Variations• Managing Regulatory Dashboards to ensure Accuracy and Visibility of Country Requirements• Collaborating with the Global Change Control Secretariat and the Global Change Control Committee to Develop Supply and Implementation Timelines• Developing Risk Mitigation Plans and Implementing Corrective Actions to Mitigate Impact to Supply and Launch Timelines• Continuous Improvement of the Change Control Process
Education
New Jersey Institute of Technology
Bachelor's Degree, Chemical Engineering, Applied Mathematics
2010 — 2014
Skills
- Project Management
- Statistics
- Analytical Chemistry
- Emerson Deltav
- Trend Analysis
- Research
- Biotechnology
- Trackwise
- Technology Transfer
- Osisoft Pi
- Data Management
- Nanotechnology
- Dissolution Testing
- Polymath
- Life Sciences
- Data Analysis
- Multivariate Analysis
- Simca
- Process Simulation
- Microsoft Word
- Powerpoint
- Microsoft Excel
- Team Leadership
- Microsoft Office
- Teamwork
- Drug Delivery
- Engineering Management
- Lims
- Discoverant
- Hydrophobic Interaction
- Ftir
- Dashboarding
- Aspen Plus
- Leadership
- Matlab
- Gmp
- Chemical Engineering
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