Quality Assurance Professional
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* The Quality Systems Specialist will ensure the quality and integrity of products.
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* Drive quality performance metrics and continuous improvement within owned systems.
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Responsibilities:
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1. Complete sub-system responsibilities per site System Ownership List.
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2. Serve as Quality SME for validation across Drug Substance and Drug Product operations.
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3. Participate in committees such as PVC, WVC, CVG, and EQVC.
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4. Approve validation documentation and support capital projects.
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5. Maintain validated state post-change; develop summary reports and quality plans.
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6. Principal Quality contact for all site change requests affecting processing.
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7. Conduct full lifecycle reviews for change controls and material strategy assessments.
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8. Provide QA oversight for laboratory systems, documentation, and incidents.
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9. Approve stability reports and support OOS investigations.
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10. Act as the Microbiology QA Point of Contact for all microbiology-related issues.
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About Our Organization
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Our company is a leading multinational organization based in Ireland. We are committed to delivering quality and excellence in everything we do. We offer a dynamic and supportive work environment that fosters growth and development for our employees.