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.
