QA System Validation Supervisor

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Job Summary

Fiche de poste :

• 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
  

Qualifications

• 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
  

Tasks Identified

• 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.
  

Type De Contrat