Quality Assurance Role
Our organization is seeking a Chief Quality Assurance Officer to support us in Clonmel. In this position, you will play a key role in ensuring the quality of our products and processes.
Responsibilities:
* Review and approve batch, cleaning and testing documentation.
* Document, assess and associate CAPA on Laboratory Out of Specification (OOS) and process deviations.
* Support deviation investigations and process performance monitoring.
* Identify root cause and complete corrective actions.
* Provide quality requirements guidance for validation status.
* Participate in process/product Risk Assessments.
* Ensure continuous improvement to systems/processes.
* Create, review and approve quality procedures as required.
Required Experience:
* Degree or post-graduate qualification in Science, Pharmacy or equivalent.
* Quality IT system knowledge desirable (e.g. SAP, Trackwise).
* Spray drying experience desirable.
* Lean / Continuous Improvement expertise.
* GMP Requirements knowledge for Electronic/paper free operations.
* High potency manufacturing experience desirable.