What are the responsibilities and job description for the CSV Analyst position at Qualified Recruiter, LLC?
- Our client is currently building a new facility and need a CSV Analyst to help validate and deliver multiple systems to the site. These will include MES, LIMS and other site critical systems.
- Successful candidates witll assist local SMEs to ensure data integrity and local validation deliverables for the site including local adoption. You will create and maintain all local validation deliverables at the site and create Installation Verification Instruction (IVI) IQ/OQ for systems. You will create test plans and ALM Test Scripts as needed. You will also work with Service Now and Trackwise to create Change Request, Incidents, and Problems.
- More responsibilities:
- Responsible for supporting the validation activities for local and global systems
- Experience in developing and maintaining validation documentation including validation places, test protocols, test scripts, and summary reports to align with company SOP and regulatory standards
- Coordinate with technical evaluation with site subject matter experts (SMEs) of new and existing systems from a DI and CSV perspective
- Responsible for coordination with cross-functional teams to ensure the alignment of the validation activities
- Perform data integrity gap assessment and develop remediation plan for computerized systems
- Responsible for creating CAPA’s/Deviations and Change Requests in ServiceNow and Trackwise
- Requirements
- BS in Computer Science or technical field
- 5-10 years of experience with CSV
- Strong understanding of SDLC in an FDA regulated environment
- Experience creating test plans and writing test scripts in support of CSV projects
- High level of initiative and drive
- Ability to work with multiple stakeholders and drive projects through to fruition
- This is an onsite position minimum 4 days per week so candidates must be local or willing to be local for duration of the contract