Quality Assurance Professional
We are seeking a skilled Quality Assurance professional to support our operations in Clonmel. The ideal candidate will have a degree in Science, Pharmacy or equivalent and experience with quality systems.
Key Responsibilities:
* Review and approve batch, cleaning and testing documentation.
* Document, assess and associate CAPA for Laboratory Out of Specification (OOS) and process deviations.
* Provide support to deviation investigations and process performance monitoring. Trend deviations raised as required to identify improvement initiatives.
* Provide detailed knowledge of quality systems in place and ensure root cause is identified and corrective actions completed.
* Provide guidance on quality requirements to maintain validation status, including participation in process/product Risk Assessments.
* Provide feedback on re-occurring issues ensuring continuous improvement to systems/processes.
* Ensure changes controls raised are documented, assessed and completed.
* Creation, review and approval of quality procedures as required.
Requirements:
* Degree or post-graduate qualification in Science, Pharmacy or equivalent.
* Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).
* Spray drying experience desirable.
* Knowledge and demonstrated expertise in Lean / Continuous Improvement.
* Experience and knowledge of GMP Requirements for Electronic/paper free operations.
* Experience in High potency manufacturing desirable.
Apply today to discuss your qualifications further.