Associate Quality Specialist
What you need to know
You will work as an Associate Quality Specialist in a highly successful and established Pharmaceutical company in Ballydine, Co. Tipperary
The Associate Quality Specialist supports day to day QA activities in the facility. The Quality Specialist participates as a core member of the Process IPT (Integrated Process Team).
This is a contract role – 9 months
Your new job
Key duties & responsibilities:
- Participate as functional expert in the cross functional team that manages production right first time at Ballydine.
- 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 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 changes 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.
What are we looking for?
- Degree or post-graduate qualification in Science, Pharmacy or equivalent.
- Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).
- Spray drying experience desirable.
- Knowledge and demonstrated expertise in Lean / Continuous Improvement.
- Experience and knowledge of GMP Requirements for Electronic /paper free operations.
- Experience in High potency manufacturing desirable.
Apply for this job now or get in touch with Aoife on 090 64 90485.
Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. In the interest of protecting your data and informing you of your rights we will notify you should we retain your information by issuing an acknowledgement email and a request for consent where not already expressly given.
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