Quality Specialist Job Opportunity
We are seeking a highly skilled Quality Specialist to support our operations in Clonmel. The successful candidate will play a crucial role in ensuring the quality of our products and processes.
The ideal candidate will have a degree or postgraduate qualification in Science, Pharmacy, or equivalent. They will also possess knowledge of quality IT systems and experience in Lean/Continuous Improvement. Additionally, they will have expertise in GMP requirements for electronic/paper-free operations and high-potency manufacturing.
Responsibilities:
* Review and approve batch, cleaning, and testing documentation.
* Ensure all Laboratory Out-of-Specification (OOS) and process deviations are documented, assessed, and associated CAPA identified.
* Provide support to deviation investigations and process performance monitoring. Perform trending on 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 as appropriate are 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.
What We Are Looking For:
* A Degree or Postgraduate 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.
If you are a motivated and experienced Quality Specialist looking for a new challenge, we would love to hear from you.