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 Analyst
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
- Oversees quality control of software, process, and data integrity validation processes and provides guidance and support to operational teams to ensure compliance with GxP, 21 CFR Part 11, and regulatory requirements.
- Works closely and effectively with Quality Management, Validation Specialists, Business Owners, Product Owners, and Product Analysts.
- Provides guidance to research operations and IT on the interpretation of corporate and regulatory requirements (standards/policies/procedures) related to software validation, quality management, and GxP and oversee QC activities related to software, process and data integrity validation.
- Provides quality review of validation life cycle documents, including user requirement specifications, plans, testing documentation, reports, etc. in adherence with SOPs, corporate policies, standards, and government regulations to ensure completeness and accuracy.
- Provides quality review and approval through the cycle of preparation, execution, data analysis, and report writing for IQ, OQ, and PQ protocols as well as periodic review of system documentation.
- Provides quality review and approval of change request documentation related to changes that impact validated systems and/or processes.
- Supports the preparation, hosting, and follow-up of Sponsor audits/assessments and regulatory inspections where necessary.
- Participates in the development and/or review of IT standards, policies, procedures, work instructions, forms, and templates to support the QMS.
- Educates, trains, and mentors staff in QMS processes and quality improvement methods. Attends training courses, conferences or association meetings to continue to gain knowledge and share information with other members of the group or company to increase awareness of industry trends.
- Participates or leads divisional improvement efforts. Performs related work as requested.
- 5+ years of information system validation, testing, or implementation experience
- 1-3 years of working in quality assurance, quality management or quality auditing preferably working in a CRO or Sponsor environment.
- Knowledge of FDA GxP requirements for systems, 21 CFR Part 11 and FDA software validation guidelines.
- Knowledge of EU regulations, e.g., Annex 11 is helpful.
- Knowledge of industry and international standards for software quality, such as GAMP V, PIC/S, ICH, etc. is helpful.
- Pharmaceutical, biologics, CRO, and/or medical device industry 21 CFR Part 11 requirements and software validation principles.
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.
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