Quality Assurance Specialist

PROCHEM Engineering Limited

Tipperary

Role Summary: An amazing opportunity has arisen for a Quality Assurance Specialist to join our client’s busy pharmaceutical site based in Co. Tipperary.  The successful candidate will play an integral role in participating as functional expert in the cross functional team that manages production right first time on site.  Core Duties and 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 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 change controls raised are documented, assessed and completed. Prepare Annual Process and System Reviews. Act as lead /team auditor to support the internal GMP walkdown and scheduled audits. Participate in the generation and communication of quality metrics. Creation, review and approval of quality procedures as required.  Minimum Qualifications and Experience: Degree or post-graduate qualification in Science, Pharmacy or equivalent. Experience and knowledge of GMP Requirements for Electronic / Paper free operations. Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise. Knowledge and demonstrated expertise in Lean / Continuous Improvement. Digital proficiency: MS: Teams, Sharepoint, Word, Excel, Powerpoint. Experience in High Potency manufacturing desirable. Excellent written and oral communication skills. Organizes and delivers information appropriately. Interacts with people effectively. Able and willing to share and receive information. Uses sound judgement to make good decisions based on information gathered and analysed. Adapts to changing work environments, work priorities, organizational needs and diverse people. Sets and maintains high performance standards. Pays close attention to detail, accuracy and completeness. Maintains high level of productivity and self-direction. Is result orientated. To Apply: If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us: 14 Danville Business Park, Kilkenny, Ireland. +353 56 77 90100. recruitment@prochem.ie. Click here to submit your CV. Please note, we do not require agency assistance with this role.  .

880 days ago