QA Specialist

QA Specialist – Medical Devices – Dublin – Initial 12-Month Contract – Pharmaceuticals

Are you looking for the chance to support a life changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for aQASpecialistto support a project in Dublin on an initial 12-month contract.

What you’ll deliver:

• Supporting the Medical Device Quality Team in progressing the update and release of documents & records in the document management system.
• Supports Combination Product Audit readiness initiatives and support during audits.
• Supports Notified Body and Health Authority inspections and compliance.
• Responsible for collection/collation of QMS data and performing data analysis to support periodic Combination Product Management Review reports, meetings, minutes and actions.

Experience required:

• Minimum of a bachelors degree or equivalent experience in a regulated industry.
• Knowledge of the regulatory and compliance requirements for medical devices and/or combination products (e.g. FDA QMSR 21 CFR Part 820 and Part 4 / ISO 13485 and Regulation (EU) 2017/745), ISO 14971.
• Experience using electronic QMS / document management systems (e.g., Veeva Vault) for document lifecycle, quality events, and action tracking.
• Demonstrated experience managing quality or compliance- related projects in a regulated medical device and/or combination product environment.  

If you are interested, please apply now for immediate consideration and further information.
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