Eve Kulcsar
- Role
- Senior Validation Consultant at Automated Systems, Inc. (ASI)
- Location
- Chicago, IL, US
- LinkedIn followers
- 500 followers
About Eve Kulcsar
Accomplished technical professional with extensive experience equipment and process…
Experience
Senior Validation Consultant
Dec 2011 — Present
Functions as a consultant in the Medical Device industry. Authors and executes validation documentation for new and existing automation equipment; FAT, SAT, IQ/OQ/PQ. Supports Engineering initiatives as needed. Focuses on generating objective evidence which documents accomplishments in Quality Systems improvement. Aids in CAPA investigations. Supports Quality objectives as needed.
Skills
- 21 Cfr Part 11
- Hplc
- Standard Operating Procedure (Sop)
- Software Documentation
- V&V
- Capa
- Quality Auditing
- Cross-Functional Team Leadership
- Wet Chemistry
- Fda
- Quality System
- Sop
- Manufacturing
- Verification and Validation (V&V)
- Gmp
- Validation
- Medical Devices
- Continuous Improvement
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