Quality Specialist

Quality Specialist - Life Science - 11-Month Contract - Clonmel

Our Partner in Tipperary area develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. The plant, which has been operating in Clonmel for over 40 years, exports to over 25 countries around the world with primary markets being Europe, USA and Japan.

They require a Quality Specialist to support them at their facility in Clonmel.

Quality Specialist Responsibilities :

• 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.
• Creation, review and approval of quality procedures as required.

Experience required as a Quality Specialist :

Are you a good fit for a Quality Specialist? Get in touch with us today.

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