Quality Assurance Specialist
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| Job Type | Contractor |
| Location | Dublin |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Darcy Ainscough-Denton |
| Telephone | +353 1 574 6266 |
| Job Ref | 1002749 |
| Job Views | 116 |
- Description
- Team Horizon is seeking a Quality Assurance Specialist III (initial 12-month contract) for our client, who are a leading biopharmaceutical company. In this role you will be join the Quality Compliance team and will support the global supplier and material approval of processes including migration of site-based processes to the global process.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
Our client has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.
What you will be doing:
Support the global supplier and material approval processes including migration of site-based processes to the global process.
Suppoert management of Quality Agreements.
Support Supplier Change Notification process to ensure appropriate change control and regulatory updates have been made prior to making changes.
Support monitoring of approved Suppliers through data gathering and reporting.
Support periodic review of approved Suppliers.
Gather data and report quality metrics for internal processes and identify and implement improvement opportunities.
Support Continuous Improvement of the Supplier Quality System.
Support audits and inspections, as appropriate.
Perform all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements.
What you need to apply:
Minimum of 4+ years’ experience in Quality with medical device, pharmaceutical, or biologics experience.
Experience in Supplier Quality, Material Qualification, Procurement, Quality Assurance, or Auditing.
Experience with Quality Risk Management and Structured Problem-Solving tools.
A strong customer focus and ability to prioritize and adapt to business needs.
Knowledge of applicable international GXP regulations and standards.
Strong business partner with a focus on delivering results.
Excellent written and verbal communication skills.
Strong ability to analyse systems, data.
Capable of identifying and mitigating risks.
Experience with high performance teams, cross functional projects.
Experience with Technical Writing.
Experience working with mature supplier quality system.
Previous global Quality System development/deployment experience.
Experience supporting regulatory inspections.
