Address
Form of work 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
