Qa Associate

Summary:
A QA Associate is required for a biopharmaceutical company in South Tipperary. The incumbent will ensure that all Laboratory Out of Specification and process deviations are documented, assessed and associated CAPA identified.
Responsibilities: 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.Qualifications & Experience: 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.Excellent written and oral communication skills.
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