Job Title: IT GRC Risk & Compliance
Location: Cordova, TN- 38016
Job Description for Life Science Quality and CSV Lead
This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, GLP) quality and compliance environment. This position is also responsible for monitoring Computer System validation (CSV), Qualification activities (IQ,OQ,PQ) as well as compliance with 21 CFR Part 820 and 21 CFR Part 11.
1. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Reviews validation documents such as IQ, OQ, PQ’s.
2. Setup Quality Management System (QMS) to direct and control with regard to quality as per different regulatory (FDA) and ISO 9001 requirements. Create documented set of procedures and standards
3. Prepare, review and approve procedures such as Backup and Recovery, Server Build, Anti-Virus, Asset Management, Problem Management, Change Management, Patch and Release Management, Performance Capacity Management, Physical Access and Security, Training Administration, Server Decommission, Account Management and other procedures as applicable
4. Develop and establish quality assurance standards and measures for the information technology services within the organization.
5. Assure compliance with GxP (GMP, GCP, GLP), Privacy, HIPAA requirements. Develops and maintains IT GxP compliance documentation.
6. Ensure GxP Computerized Systems are validated as per GAMP -5 requirements.
7. Plan, conduct and report routine GxP audits including third party audits.
8. Lead the execution of the audit activities associated to GxP and appropriate applicable regulatory requirements. Enable team to be inspection ready and support a culture of sustainable compliance
9. Participates in Corrective and Preventive Action (CAPA), Maintains quality metrics.
Desired skills / certifications / training
1. 10+ years in Quality, Compliance, Computer System Validation, Auditing, Writing policies/procedures in Life Science
2. Excellent knowledge of cGMPs, , FDA and EMEA guidelines including 21 CFR Part 820, 21 CFR Part 11
3. Excellent knowledge of computer system validation and GAMP -5 standard.
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