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 throughout their lifecycle and engage with all stakeholders involved in product quality.
* Competitive salary/rates
What you will be doing:
* Supporting weekly, monthly, and quarterly QMS governance reporting.
* Collecting QMS data and performing data analysis to support periodic product management review reports, meetings, minutes, and actions.
* Partnering with Central Quality Systems and Compliance (CQSC) to ensure successful deployment of a combination product QMS.
* Supporting cross-functional teams with review board meetings (e.g., change control, supplier change, change planning, standards review planning) and updating supplier quality agreements.
* Documenting and periodically reviewing supplier quality requirements and agreements.
* Assisting the Medical Device Quality Team with document updates and releases in the document management system.
* Ensuring timely entry, processing, and closure of quality records in compliance with procedures.
* Supporting Notified Body and Health Authority inspections and compliance activities.
* Supporting audit readiness initiatives for combination products.
* Participating in periodic reviews and collaborating across functions to incorporate stakeholder feedback into document updates.
* Supporting process improvements through gap analysis of SOPs or processes against standards and regulations, and updating them accordingly.
* Communicating effectively internally and externally.
* Adhering to company quality assurance and regulatory requirements.
* Performing other duties as assigned.
What you need to apply:
* Bachelor’s degree in biological, chemical sciences, biomedical, mechanical engineering, or related fields.
* At least 4 years of experience in Quality within a regulated environment.
* Knowledge of FDA 21 CFR Part QSR, ISO standards, and EU MDR regulations.
* Familiarity with SAP, Veeva Vault, and Trackwise is desirable.
* Ability to work independently and as part of a team in a fast-paced environment.
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