QA Validation Specialist

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 guidelinesDefine 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