Vacancy expired!
- Provide CSV Support for IT and Engineering Projects.
- Ensure that proper Computer Systems Validation procedures are followed during system implementations
- Creation and/or Review Computer Systems Validation documents for various projects.
- Work with vendor provided CSV documents for review and routing for approval
- Work with project managers/SMEs/IT Leads to collaborate on User and functional requirements for systems.
- Routing/Tracking CSV Documents for approval.
- Monitor the status of documents out for approval and inform project managers when their documents are approved
- Oversee Test executions, Review Executed protocols, write up protocol deviations and prepare documentation sets for approvals.
- Provide training for Test Execution methodology to testers prior to test execution.
- Maintain CSV Documentation.
- Manage IT Change Control process
- Perform/Track Periodic Review/Compliance Monitoring of validated systems.
- Knowledge of GxP Compliance with respect to Computer Systems
- Knowledge of 21CFR Part 11 and GAMP 5
- MS Office suite
- Good time management skills and the ability to multitask and complete tasks in a timely manner.
- Analytical skills & ability to pick up requirements, workflows and system navigation for IT applications.