Major Responsibilities
- Oversee the computerized system life cycle and ensure compliance with GxP standards and established procedures.
- Develop and maintain Computer System Validation (CSV) plans in alignment with 21 CFR Part 11 requirements.
- Manage deviations, change controls, investigations, and CAPA protocols.
- Author CSV protocols and related documentation.
- Review and approve documents before and after execution.
Job Qualifications / Minimum Requirements
- At least 3 years CSV exp and 1-year exp with Emerson DeltaV hardware/software system
