QA Associate
Tandem Project Management
- Carlow
- Contract
- Full-time
A QA Associate is required for a biopharmaceutical company in Carlow. 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.
- 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.
- Excellent written and oral communication skills.