- 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.
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
Please note, we do not require agency assistance with this role.