QA Validation Specialist

3 weeks ago

Apex, United States Katalyst HealthCares & Life Sciences Full time
Responsibilities:
  • Managing Quality Engineering and Validation (QEV) Validation programs for the facilities, utilities, manufacturing and QC lab equipment, computerized systems and associated processes.
  • Responsible for maintaining and ensuring site compliance to corporate policies and procedures for the validation of systems.
  • Perform Validation Risk assessments and Data Integrity evaluations in support of Validation Lifecycle Management (VLM) of equipment, facilities, utilities, processes.
  • Ensure Qualification/Validation activities are completed in accordance with project timelines.
  • Support enterprise, cross functional, and validation activities, in providing approach, methodology, and deliverables in compliance with 21 CFR Part 11, 58, 210 and 211, Eudralex regulations and ICH guidelines
  • Define the validation strategy and associated project plan for systems at JEB and work with the applicable stakeholders to implement and then execute.
  • Oversee future validation efforts associated with the operation of all GMP manufacturing systems, equipment and computer systems. Perform SDLC validation planning for each computerized system to ensure complete, successful end-to-end qualification of electronic systems, including system interfaces and infrastructure usage.
  • Provide oversight to the overall computer system validation master plan, including interactions with other Just-Evotec entities responsible for related non-site-based computer systems.
  • Build, teach, and act as a resource for a team of Quality Engineers with varying experience Levell

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