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Validation Specialist with LIMS
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- uthors, executes and/or reviews validation documents such as validation project plans, validation protocols, validation reports, risk management tools, gap analysis, CAPA and validation exceptions/deviations for Computer and IT systems.
- Expertise in MES/Delta-V/LIMS/Lab Equipment and Manufacturing CSV systems.
- Schedules and executes validations per ASTM, GAMP V, standard operating procedures, and regulatory guidelines.
- Lead assigned validation-related investigations and conduct data integrity (DI) assessments with DI remediation planning.
- Champion and lead continuous improvement efforts on every aspect of validation.
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