Quality Specialist - Life Science - 11-Month Contract - ClonmelOur 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:Degree or post-graduate qualification in Science, Pharmacy or equivalent.Knowledge of Quality IT systems desirable (e.g.
SAP, Trackwise).Spray drying experience desirable.Knowledge and demonstrated expertise in Lean / Continuous Improvement.Experience and knowledge of GMP Requirements for Electronic / paper free operations.Experience in High potency manufacturing desirable.Are you a good fit for a Quality Specialist?
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