Overview
On Site
Full Time
Skills
Business Requirements Gathering
Risk Assessment
Test Plans
Data Migration
Test Scripts
Traceability Matrix
Management
Testing
Quality Assurance
Regulatory Compliance
Inspection
Documentation
Microsoft Office
Microsoft Visio
Document Management
EMC Documentum
Application Development
Lifecycle Management
Application Lifecycle Management
JIRA
IT Service Management
ServiceNow
SAP Solution Manager
English
Communication
Computerized System Validation
Organizational Structure
Job Details
Roles & Responsibilities:
- 8-10+ Years of Overall IT Experience
- Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix.
- Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the integrity of the data, or the system Obtain and respond to QA review.
- Participate in establishing standard quality and validation practices Independently assess compliance practices and recommend corrective actions.
- pprove validated computer system related change requests Monitor regulatory and inspection trends and advise the business on suitable action.
- bility to create documents to an existing document standard.
- ble to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.
- dvanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project.
- Experience with electronic document management systems (e.g. Documentum, Qumas, SharePoint etc.); application development and lifecycle management (e.g. Client ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc).
- Excellent oral and written communication skills in English.
- Strong expertise and ability to interview and accurately interpret communication requirements of team members.
- Once trained, have the ability to work independently on CSV projects with minimal oversight
- bility to perform in a highly matrixed organization structure.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.