Casey Riffe
- Role
- Senior Specialist, Computer Systems Validation at Jubilant Pharmova Limited
- Location
- Spokane, WA, US
- LinkedIn followers
- 500 followers
About Casey Riffe
High quality team leader, with years of IT experience running efficient teams. A…
Experience
Senior Specialist, Computer Systems Validation
Jan 2020 — Present
Document all computer based system projects for FDA 21 CFR Part 11 compliance • Utilizing the V model of CSV, document new systems and software for FDA 21 CFR Part 11: • User Requirements Specification (URS) • Validation Master Plan (VMP) • Infrastructure (IQ), Operational (OQ), and Performance Qualification (PQ) • Design Configuration Specifications (DCS) • Design Configuration Reports (DCR) • Risk Analysis Reports • Requirements Traceability Matrix (RTM) • Release / Go-Live Memos • Validation Summary Reports • Complete risk assessments for new computer based systems and software • Audit new and existing vendors for IT best practices, good documentation practices, and FDA compliance • Manage GMP certification required FDA regulated facility • Write, review and approve validation Standard Operating Procedures (SOPs) • Maintain all validation documentation • Represent Jubilant Pharma in front of FDA auditors for Computer Systems Validation audits • Review and analyze validation data, and compile reports to management • Drive organization change based on proposal from FDA: Computer Systems Validation to Computer Software Assurance model • Act as point of escalation for support for global organization for SQL and Windows based systems • Act as PM, and various projects and documentation of processes and SOPs as assigned
Skills
- Databases
- Business Process
- Project Management
- Enterprise Software
- Problem Management
- Business Intelligence
- Microsoft Sql Server
- Process Improvement
- Microsoft Project
- Server Architecture
- Iis
- Itil
- Widnows Server Administration
- Sharepoint
- Vendor Management
- Application Support
- People Management
- Ms Project
- .net
- Data Center
- C# 4.0
- Product Studio
- Cloud Computing
- Scrum
- Quality Assurance
- Software Project Management
- Biztalk
- Agile Methodologies
- Testing
- Sdlc
- Program Management
- Visio
- Management
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