Biotechnology Quality Assurance Expert
1 day ago
We are seeking a Biotechnology Quality Assurance Expert to join our team at TN Ireland. As a Quality Systems Specialist, you will be responsible for providing quality assurance expertise in a regulated environment.
About the Role:
- We are looking for an experienced professional with a strong background in quality assurance and regulatory compliance.
- The ideal candidate will have a deep understanding of FDA 21 CFR Part QSR, ISO, and EU MDR regulations.
- You will work closely with cross-functional teams to ensure seamless implementation of quality management systems and regulatory requirements.
Your Responsibilities:
- Support 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.
- 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.
- 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.
About You:
- You have a 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.
- You have 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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