Duration: 12+ Months
Parallon Technology Solutions (PTS) is seeking a Validation Specialist in Nashville, TN. The Validation Specialist is responsible for supporting the validation strategy and policies. Participate on computerized system validation and implementation of project teams. Authorize computer system validation documentation ensuring compliance with applicable regulations.
- Ensure continued regulatory compliance during software implementation projects and structured development life cycle practices and methodologies.
- Authoring validation/qualification deliverables including but not limited to risk/impact assessments, validation plans, design specifications, requirements traceability, and validation summary reports.
- Assist in the development of detailed requirements for each new validated system.
- Assist with developing test strategies and defining test data (i.e. design the approach for testing each requirement).
- Assist with authoring validation and verification testing protocols/scripts (i.e., IQ, OQ, PQ).
- Coordinate 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-conformances/deviations.
Parallon Technology Solutions, LLC. (PTS) provides EHR implementations, application support, IT managed services, hosting, technical staffing and strategic IT consulting services to hospitals, outpatient facilities, accountable care organizations and large physician groups nationwide. With a team of over 400 clinical, financial and technical professionals, PTS has implemented EHR systems in more than 300 facilities. PTS offers staffing and remote support services for all major EHR acute and ambulatory platforms as well as their ancillary applications. Company offers competitive pay and comprehensive benefits including medical, dental, life, 401K match and employee stock purchase opportunities.
- 3+ years of information systems management, testing, and implementation experience.
- Experience of FDA/GCP compliance and a proven track record of execution and results.
- 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, ICH, etc is preferred.