Associate Quality Specialist
Darwin Rhodes
- Clonmel, Co Tipperary
- Permanent
- Full-time
- Participate as functional expert in the cross functional team that manages production right first time.
- 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 change 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.
- Review and approve batch, cleaning and testing documentation.
- Degree or post-graduate qualification in Science, Pharmacy or equivalent.
- Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise, Document Management Systems).
- Knowledge and demonstrated expertise in Lean / Continuous Improvement.
- Experience and knowledge of GMP Requirements for Electronic /paper free operations.
- Communications: Excellent written and oral communication skills. Organizes and delivers information appropriately.
- Team Work: Interacts with people effectively. Able and willing to share and receive information.
- Decision Making: Uses sound judgement to make good decisions based on information gathered and analysed.
- Adaptability: Adapts to changing work environments, work priorities, organizational needs and diverse people.
- Work Standard: Sets and maintains high performance standards. Pays close attention to detail, accuracy and completeness.
- Motivation: Displays energy and enthusiasm. Maintains high level of productivity and self-direction.
- Legally authorized to work in Ireland.