Location:
Clonmel, Ireland
Type of contract
: contract of employment, fixed term
Length of contract
: 11 months with possible extension
Pay rate
: EUR/ hour
Work model
: 5 days on site
Client:
A premier research-intensive biopharmaceutical company, committed to being at the forefront of research, delivering innovative health solutions that advance the prevention and treatment of diseases in both people and animals.
The Quality Specialist role:
* Participate as functional expert in the cross functional team that manages production right first time at site.
* 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 skills you will need:
In order to excel in this role, you will more than likely have:
* Degree or post-graduate qualification in Science, Pharmacy or equivalent.
* Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).
* 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.
* 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.