Team Horizon is seeking a Quality Systems Specialist for our client, a leading Biotechnology company in Dublin. This is a 12-month initial contract.
Why you should apply:
* Exciting opportunity to provide QMS support for combination products for the product lifecycle and the associated Quality System and engage with all stakeholders involved with product quality.
* Competitive salary / rates
What you will be doing:
* Supports weekly/monthly/quarterly QMS governance reporting.
* Responsible for collection of QMS data and performing data analysis to support periodic Combination Product Management Review reports, meetings, minutes and actions.
* Partner with Central Quality Systems and Compliance (CQSC) to ensure successful deployment of a combination product Quality Management System.
* Support cross functional teams with review board meetings (e.g. Change control, Supplier Change, change planning, Standards review planning) and Supplier Quality Agreement updates.
* Support documenting and periodic review of supplier quality requirements and supplier quality agreements.
* Supporting the Medical Device Quality Team in progressing the update and release of documents & records in the document management system.
* Ensure timely entry, processing, and closure of quality records in compliance with procedures.
* Supports Notified Body and Health Authority inspections and compliance.
* Supports Combination Product Audit readiness initiatives.
* Supporting Periodic Review and working cross functionally to ensure stakeholder feedback is included in any document updates.
* Support process improvements by gap analysis of existing SOPs or processes against medical device standards and regulations and making updates accordingly.
* Communicate effectively, both verbally and in writing, internally across departments and with external partners.
* Comply with the company quality assurance requirements as well as applicable regulatory requirements.
* Other duties as assigned.
What you need to apply:
* Minimum of a bachelor’s degree in biological/chemical sciences, biomedical/mechanical engineering, or other related subject.
* Minimum of 4+ years’ experience in Quality in a regulated environment.
* Knowledge of the regulatory and compliance requirements of FDA 21 CFR Part QSR, ISO, EU MDR.
* Familiarity with SAP, Veeva Vault and Trackwise would be desirable.
* An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
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