Summary:
A Quality Specialist is required for a pharmaceutical company in South Tipperary. The successful candidate will review and approve batch, cleaning and testing documentation.
Responsibilities:
* Participate as functional expert in the cross functional team that manages production right first time at site.
* Review and approve batch, cleaning and testing documentation.
* Ensure that 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 that 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.
* Prepare Annual Process and System Reviews.
* Act as lead/team auditor to support the internal GMP walkdown and scheduled audits.
* Participate in the generation and communication of quality metrics.
* Creation, review and approval of quality procedures as required.
Qualifications & Experience:
* Degree or post-graduate qualification in Science, Pharmacy or equivalent.
* Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).
* 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.
* Excellent written and oral communication skills, organizes and delivers information appropriately.