Associate Quality Specialist
Reference: | RK21125 |
Location: |
Tipperary
|
Qualification: | Degree | Experience: | 2-3 Years |
Job Type: | Fixed Term Contract | Salary: |
Not Disclosed |
Associate Quality Specialist
RK21125
Contract – 12 months
Tipperary
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Tipperary. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties:
- Participate as functional expert in the cross functional team that manages production right first time.
- 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 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.
- Review and approve batch, cleaning and testing documentation.
Experience and Education
- Degree or post-graduate qualification in Science, Pharmacy or equivalent.
- Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise, Document Management Systems).
- Knowledge and demonstrated expertise in Lean / Continuous Improvement.
If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or [email protected] for further information.