Overview
Quality Specialist - Life Science - 11-Month Contract - Clonmel. Our partner in the 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.
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.
Qualifications
* 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? Get in touch with us today.
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