Associate Quality Specialist
RK20103
Contract – 11 months
Tipperary



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Tipperary. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



Duties:

• Participate as functional expert in the cross functional team that manages production right first time at Ballydine.
• 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.



Experience and Education:

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).
• Spray drying experience desirable.



If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or rachel.kent@lifescience.ie for further information.