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Quality Assurance Validation Engineer
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- Perform validation document Gap Analysis for equipment with QC and Manufacturing Operations and support the implementation of remediation plans
- Provide QA/QV support for continuous improvement projects, including data integrity initiatives within the laboratory and manufacturing environment.
- Work with Manufacturing Operations, Quality, in-house technical groups, and other site/networks as required to assist with establishing validation plans, validation strategy, specifications, and qualification protocols
- Provide QA/QV support in the implementation of change controls and commitment action items
- Broad knowledge FDA and international regulations related to GMPs and Pharmaceuticals
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