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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 Tipperary for over 40 years, exports to over 25 countries around the world with primary markets being Europe, USA and Japan. We are recruiting a QA Specialist to work here on an 11 month contract basis.
Essential Duties and Responsibilities for this QA Specialist role include, but are not limited to, the following:
- 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.
Requirements as a QA Specialist:
- Degree or post-graduate qualification in Science, Pharmacy or equivalent.
- Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).
- 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.
If you are interested and have the above experience, please apply now.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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