Associate Quality Specialist
at Aphex Group
Tipperary, County Tipperary, Ireland -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 09 Jul, 2024 | Not Specified | 10 Apr, 2024 | N/A | Continuous Improvement | No | No |
Required Visa Status:
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Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
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Contract to Hire – Corp 2 Corp |
Description:
REQUIREMENTS
- 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.
- Experience and knowledge of GMP Requirements for Electronic /paper free operations.
Responsibilities:
PURPOSE
Associate Quality Specialist supports day to day QA activities in the facility.
RESPONSIBILITIES
- 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.
- Communications: Excellent written and oral communication skills. Organizes and delivers information appropriately.
- Team Work: Interacts with people effectively. Able and willing to share and receive information.
- Decision Making: Uses sound judgement to make good decisions based on information gathered and analysed.
- Adaptability: Adapts to changing work environments, work priorities, organizational needs and diverse people.
- Work Standard: Sets and maintains high performance standards. Pays close attention to detail, accuracy and completeness.
- Motivation: Displays energy and enthusiasm. Maintains high level of productivity and self direction.
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
Science pharmacy or equivalent
Proficient
1
Tipperary, County Tipperary, Ireland