Eugene Charron                                                                                                                                  

Technician

Eugene has over 5 years experience with Computerized Systems Validation (SAP, Trackwise, Cyberdocs, Excel workbooks, and other proprietary systems), 21 CFR Part 11, Change Control, Documentation, Investigation and Deviation Databases. He also has extensive experience with computer system administration, development, and support including database design, SQL, and Visual Basic.

Experience…

• Designed, validated, and implemented automated tracking system for controlled substances with record time stamps (audit trail) and inventory calculation using Microsoft Access and Visual Basic 6.0.  Developed and implemented system for Inventory and asset traceability including automated issuance of data to appropriate users in a secure manner using MS Access and Visual Basic 6.0.
• Developed, validated, and successfully implemented a system which facilitates the publishing of product trending data to the site intranet for use by executive management in a “user-friendly” yet secure format using MS Excel and Visual Basic with some Crystal Reporting.
• Created daily notification system in MSAccess and Visual Basic 6.0.  Revised, performed training, and implemented documentation and change control procedures site-wide while maintaining communication with upper management and meeting desired project target dates.
• Successfully coordinated and executed Quality Systems transfer of all information and documentation systems to multiple sites (including international sites).  This included dealing with 3 distinct IT groups, 7 different databases, and approximately 30 pallets of paper documentation.
• Worked on Trackwise implementation project in SQL Server.  Rolled out Trackwise Change Tracking system.  Implemented security procedures and training for all Quality Systems databases. 
• Successfully achieved corporate compliance deadline for compliance with 21 CFR Part 11 Regulations by assessing 107 systems and performing remediation on 8.  Was successfully audited twice without major observation.
• Routinely updated database information and performed Ad-Hoc reporting.  Created “Backend/Frontend” system of publishing document information site-wide that allowed for secure information to be viewed by all authorized personnel resulting in decreased amount of “paper reporting” and increased the visibility of the systems. 

Positions Held…

• Technician                                                               BioTeknica
• Compliance Program Mgr.                                        Aveva Drug Delivery Systems 
• Quality Assurance Administrator                            Aveva Drug Delivery Systems 

Education…

• Associate in Arts                                                     Broward Community College (BCC) graduating in Dec ’05

Additional Education/Skills…

• Database Design/Architecture (Relational and Object-Oriented)
• cGMP Compliance Technical Writer and Proofreader
• GAMP Guidelines for Systems Design and Validation
• Developer Level knowledge in MS Office products (including macro building and automation techniques)
• Visual Basic 6.0
• PL/SQL
• Systems Analysis, Design, and Implementation Techniques
• 21 CFR Part 11 Compliance
• Moderate level programming skills (C++, HTML, Unix)
• SAP Modules Training (Quality Module (QM), Product/Planning(PP), Inventory Management(IM))
• DEA Level 2 Clearance