Job Description
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We are seeking a Quality Assurance Professional to support our operations in Clonmel. As a key member of our team, you will be responsible for ensuring the quality of our products and processes.
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Responsibilities:
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1. Review and approve batch, cleaning, and testing documentation.
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2. Evaluate and document Laboratory Out of Specification (OOS) and process deviations, identifying root causes and implementing corrective actions.
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3. Support deviation investigations and process performance monitoring, analyzing data to identify trends and improvement initiatives.
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4. Provide guidance on quality requirements, ensuring validation status is maintained through participation in process/product risk assessments.
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5. Contribute to continuous improvement by identifying and addressing re-occurring issues.
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6. Ensure changes controls are documented, assessed, and completed.
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7. Develop, review, and approve quality procedures as required.
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Requirements
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8. Degree or postgraduate qualification in Science, Pharmacy, or equivalent.
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9. Familiarity with Quality IT systems (e.g., SAP, Trackwise) desirable.
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10. Spray drying experience desirable.
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11. Knowledge and demonstrated expertise in Lean/Continuous Improvement.
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12. Experience and knowledge of GMP Requirements for Electronic/Paper-free operations.
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13. High potency manufacturing experience desirable.
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About This Opportunity
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This role offers an exciting opportunity to join our team and contribute to the success of our organization.
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