QA System Validation Supervisor

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Job Description:

Job Summary

The Healthcare Quality Assurance (QA) System Validation Supervisor provides guidance to UPS Supply Chain Solutions (SCS) Information Technology (IT) department to maintain validation of warehouse and/or support systems utilized for healthcare applications. This position assesses systems being evaluated for use in healthcare applications and provides training and subject matter expertise to achieve and maintain validated status. He/She identifies systems requiring validation, elevates validation issues appropriately, and provides validation expertise. This position manages validation documents, determines applicable regulations, and reviews and approves testing of changes to validated systems.

Job Description

• Knowledgeable in 21 CFR Part 11, Annex 11, and GAMP 5
• Updates validation procedures, including change control, training, and audits, to ensure the maintenance of system validation.
• Writes and reviews technical validation documents (e.g., validation plan, URS, FRS, Risk Assessment, Traceability Matrix, IQ/OQ/PQ/OPQ protocol, report, etc.)
• Assists in system validation project activities (e.g., writing protocols, reviewing/approving test scripts, drafting validation reports, etc.)
• Review and approve Change Control requests and assesses the impact on system validation status.
• Review and approve procedures, forms, and manuals.
• Perform audit trail reviews and document results.
• Perform system validation status evaluations and complete reports.
• Assist with supplier qualification assessment data gathering.
• Investigate, review, approve, and perform corrective actions for deviations (i.e., nonconformances and CAPAs) and audit findings.
• Maintains the document management system for healthcare facilities and distribution centers to ensure required documents and data are available for regulatory agency audits and inspections
• Supports internal and external audits
• Supports validation project status reports to communicate project goals, contingency plans, and issue resolutions to project teams and clients
• Supervise direct reports, as appropriate
• Lead cross functional groups
• Flexible to work in different time zones
  
  

• Bachelor’s degree in a relevant field (e.g., Information Technology, Computer Science, Data Science, or related discipline).
• Overall, 7 years of experience with 2+ years of experience in quality assurance, manufacturing, or compliance within a GMP-regulated industry.
• Knowledgeable in 21 CFR Part 11, Annex 11, and GAMP 5
• Must be an effective collaborator and communicator
• Must be well organized
• Must have proficiency with Microsoft Excel, word and PowerPoint.
• Knowledge of Process Analysis/Continuous Improvement are required
  
  

• Provides guidance to UPS Supply Chain Solutions (SCS) Information Technology (IT) and Engineering departments to maintain validation of warehouse and/or support systems utilized for healthcare applications.
• Identify systems used in healthcare that require validation and assess and evaluate the applications for system validation requirements.
• Consults with internal groups (e.g., Operations, Business Development, IT, etc.) and investigates and resolves healthcare issues to ensure compliance with rules and regulations.