Contract Contract Length:
At CereCore, our heart for healthcare is interconnected with our knowledge of technical solutions, creating a vital link that ultimately drives the delivery of high-quality care. CereCore
is a wholly-owned subsidiary of Hospital Corporation of America (HCA) Healthcare. CereCore
is seeking a Senior Validation Specialist
to join our team in Nashville, TN.
This individual will work on-site
at one of the nation's leading providers of healthcare services, HCA Healthcare
- Participate on computerized system validation and implementation project teams.
- Author computer system validation documentation ensuring compliance with applicable regulations.
- Participates on project teams (i.e., business, research applications, developers, IT Infrastructure and Security) throughout the installation, configuration, testing, and implementation process.
- Works with development teams in translating functional requirements into clearly specified product features.
- Works with other Information Technology teams for potential integration/functionality with existing applications.
- Ensures continued regulatory compliance during software implementation projects and structured development life cycle practices and methodologies.
- Authors validation deliverables including but not limited to risk/impact assessments, validation and qualification plans, design specifications, requirements traceability, and validation summary reports.
- Works with Product Analyst/Business Analyst in the development of detailed requirements for each new validated system
- Develops test strategies and defines test data (i.e. design the approach for testing each requirement).
- Authors validation and verification testing protocols/scripts (i.e., IQ, OQ, PQ).
- Coordinates and oversee execution of validation and verification testing protocols/scripts for software under development and/or commercial off the shelf software products including identification and resolution of non-conformance/deviations.
- Evaluates changes to the validated state of systems and determines validation requirements for applications through change control procedures and participate in the planning and implementation of changes; ensures completion of validation documentation before changes are implemented.
- Tracks and manages change control activities for multiple concurrent projects.
- 5+ years of information system validation, testing, or implementation experience
- Must have a working knowledge of FDA regulations in clinical research
- Knowledge of FDA GCP requirements for systems, 21 CFR Part 11 and FDA software validation guidelines
- Knowledge of EU regulations, e.g., Annex 11 is preferred
- Knowledge of industry and international standards for software quality, such as GAMP V, PIC/S, and ICH is preferred
- Familiar with Agile Methodology preferred
- Leads in communicating requirements to development, testing, education and training teams
was formed in 2001 as a shared service business within a large hospital operator. We focus solely on helping healthcare organizations align business and IT strategies to improve processes and patient care.
Connect with us on LinkedIn, Twitter