Lisa Wyeth
Computer System Validation Manager at SK pharmteco
- Role
- Computer System Validation Manager at SK pharmteco
- Location
- Southampton, PA, US
- LinkedIn followers
- 500 followers
About Lisa Wyeth
A highly accomplished Computer System Validation engineer with IT Operations and Compliance with 18+ years of experience in Information Technology. Vast experience in validating computer system software Custom off the shelf (COTS), Laboratory Information Management Systems (LIMS) and procurement of equipment for large pharmaceutical and biotechnology organizations. Vast experience with working on all phases of the System Development Life Cycle (SDLC). Vast knowledge with all aspects of IQ, OQ and PQ protocols. Exemplary record in developing and executing implementation plans within tight deadlines and budgets. Vast experience with all the facets of Quality Assurance. Currently manage a validation team of approximately seven team members who are all fulltime employees locate on and off site. I am a clear communicator, with outstanding management skills.
Experience
Computer System Validation Manager
Aug 2024 — Present · King of Prussia, PA, US
Education
University of Phoenix
Bachelor's degree, Information Technology
Strayer University
Master's , Management Information Systems, General
Villanova University
Master Certificate in Applied Project Management, Project Management
2011 — 2012
Manor College
Associates Degree, Business Adminstration
1989 — 1991
Skills
- Lims
- Oracle
- Requirements Analysis
- Validation
- Technical Writing
- Automation
- Pharmaceutical Industry
- Sop
- Fda
- Glp
- Standard Operating Procedure (Sop)
- Gxp
- Clinical
- Laboratory Information Management System (Lims)
- 21 Cfr Part 11
- Good Laboratory Practice (Glp)
- U.s. Title 21 Cfr Part 11 Regulation
- Training
- Testing
- Computer System Validation
- Verification and Validation (V&V)
- Data Management
- Compliance
- U.s. Food and Drug Administration (Fda)
- Capa
- Quality Assurance
- Technical Support
- Business Analysis
- Software Documentation
- Sdlc
- Documentation
- Gmp
- Quality System
- V&V
- Change Control
- Document Management
- Regulatory Affairs
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