Computer System Validation Managers

Company: NexInfo Solutions, Inc.
Location: Santa Ana
Posted on: November 1, 2024

Job Description:

Job Title: Computer System Validation Managers (Multiple Openings)Job Description:

• Responsible for planning, executing, monitoring, and reporting of activities for FDA regulatory compliance projects of GxP systems.
• Perform Root Cause Analysis for deviations from process and agreed metrics. Perform risk management.
• Responsible for review and approval of deliverables to ensure compliance with GxP and GDP principles of FDA and other regulatory bodies.
• Facilitate and perform GMP assessments, risk assessments, manage validation services, and train team members on GxP and GDP compliance.
• Review Validation Plan, strategize, and coordinate validation activities.
• Review and provide recommendations for validation deliverables.
• Work with MS Project (MPP), Computer System Validation (CSV), Computer Software Assurance (CSA), Micro Focus ALM, GAMP5, Oracle Agile PLM, TrackWise, Veeva Vault, ServiceNow, SharePoint, 21 CFR Part 11, Annex 11, GxP, GDP, FRA, Risk Based Validation, Oracle and SAP Manufacturing & Supply Chain Applications. 40 hrs/week.
• Must have Bachelor's Degree (3 or 4 year U.S. or foreign degree) in Computer Science, Electrical Engineering, or a related field, and five (5) years of experience in the proffered position, or as a Project Manager, Validation Engineer, QA Tester, Sr. Associate-Projects, or related occupation.
• Must have 2 years of experience with planning, executing, monitoring, and reporting of activities for FDA regulatory compliance projects of GxP systems; performing Root Cause Analysis for deviations from process and agreed metrics; performing risk management; working with GxP, GAMP, GDP, 21 CFR Part 11, Annex 11, CSV, CSA, FRA, Risk Based Validation.
• Must be willing to travel/relocate to unanticipated locations throughout the US on short notice for extended periods of time.Email or Mail resume with ID#864 to US.HR@nexinfo.com, or Nexinfo Solutions, Inc., 615 W. Civic Center Drive, Suite 300, Santa Ana, CA 92701.
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Keywords: NexInfo Solutions, Inc., Hemet , Computer System Validation Managers, IT / Software / Systems , Santa Ana, California