QA Associate

Website TPM05428

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.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.