Quality Systems Specialist - Dublin, Ireland - TEAM HORIZON

TEAM HORIZON Dublin, Ireland

1 week ago

Freelance

Description

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.

Flexible working

Competetive 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.

Excellent communication & presentation skills.

An ability to work independently, as well as a member of a team in a dynamic, fast – paced environment.

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