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 Quality Specialist to work here on an 11 month contract basis.
Essential Duties and Responsibilities for this Quality Specialist role include, but are not limited to, the following:
- Complete auditing/ review of batch documentation to ensure compliance to SOPs, GMPs and applicable regulations
- Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
- Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities.
- Utilise this network to help resolve comments and issues that arise during audit and review.
- Manage product recalls and stock recoveries as appropriate.
- Identify compliance gaps and make recommendations for continuous improvement
- Create and maintain assigned SOPs.
- Perform and review complaints and deviation investigations, change controls and CAPA’s.
Requirements as a Quality Specialist:
- Degree or post-graduate qualification in Science, Pharmacy or equivalent.
- Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise)
- At least 3 years experience in a similar role, within pharmaceuticals.
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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