Quality Assurance Specialist

Summary:

12 Month Contract

Our Dublin based biopharma client is looking for a Quality Assurance Specialist to join their team for a 12 month contract. The QA Specialist will provide QMS support for combination products for the product lifecycle and the associated Quality System. The successful candidate will proactively engage with all stakeholders involved with product quality.

Responsibilities:

• Supports weekly/monthly/quarterly QMS governance reporting.
• Responsible for collection of QMS data and performing data analysis to support periodic Combination Product Management
• 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. Supporting action includes coordination of review meetings including documenting minutes & actions and filing of records.
• Supporting the Medical Device Quality Team in progressing the update and release of documents & records in the document management system.

Education and Key Competencies:

• Minimum of a bachelors 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 820 QSR, ISO 13485:2016, EU MDR.
• Familiarity with SAP, Veeva Vault and Trackwise would be desirable.

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