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.