Job Description:
We are seeking a highly skilled Quality Specialist to join our team. In this role, you will be responsible for reviewing and approving batch, cleaning and testing documentation.
* Ensure all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated Corrective Action Preventative Actions (CAPA) identified.
* Support 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 completed.
* Guide 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.
Our ideal candidate will have strong analytical and problem-solving skills, with the ability to work independently and as part of a team. They will also possess excellent communication and interpersonal skills, with the ability to collaborate effectively with colleagues at all levels.