Quality Assurance Specialist Position
We are seeking a Quality Assurance Specialist to support our facility in Clonmel. The ideal candidate will have experience in quality systems, lean/continuous improvement, and GMP requirements.
Job Description:
The Quality Assurance Specialist will be responsible for reviewing and approving batch, cleaning, and testing documentation. They will also ensure that all laboratory out of specification (OOS) and process deviations are documented, assessed, and associated CAPA identified. Additionally, the specialist will provide support to deviation investigations and process performance monitoring, perform trending on deviations raised as required to identify improvement initiatives, and provide detailed knowledge of quality systems in place.
Responsibilities:
* Review and approve batch, cleaning, and testing documentation
* Document, assess, and associate CAPA with OOS and process deviations
* Support deviation investigations and process performance monitoring
* Perform trending on deviations to identify improvement initiatives
* Provide detailed knowledge of quality systems in place
Requirements:
To be successful in this role, you will need:
* 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
About Us:
We are a leading manufacturer of innovative medicines, operating in Clonmel for over 40 years. We export to over 25 countries around the world, with primary markets being Europe, USA, and Japan.