What are the responsibilities and job description for the Computer Systems Validation lead position at Kalven Technologies?
Roles & Responsibilities
· 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. · Approve validated computer system related change requests Monitor regulatory and inspection trends and advise the business on suitable action. · Ability to create documents to an existing document standard. · Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries. · Advanced 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. HP 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. Ability to perform in a highly matrixed organization structure.
Job Type: Contract
Pay: From $55.00 per hour
Schedule:
- 8 hour shift
- Monday to Friday
Work Location: On the road
Salary : $55
