Responsibilities
- Review batch-related documentation and ensure resolution of issues to release product.
- Perform comprehensive quality review of batches for disposition.
- Ensure process control measures are in place and followed in product manufacturing
- Ensure all product-related Deviations are initiated, investigated and resolved.
- Ensure that associated CAPAs are initiated and resolved, as needed.
- Generate and update procedures, forms and other documents.
- Represent Disposition or QA Ops at plant and multi-site scheduling meetings
- Provide QA representation at multi-site disposition meetings
- Provide QA representation on projects and at team meetings
- Maintain metrics related to product disposition in support of the Management Review and for continuous improvement
- Support and participate in inspections and audits
Role is fully Onsite- 5 days a week.
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