Quality Systems Specialist

2 days ago

Nenagh, County Tipperary, Ireland Lgc Limited Full time

Job Description What you'll be doing You'll lead and support a broad range of quality systems activities, including: Implementing, maintaining, and improving our Quality Management System (QMS) Maintaining relationships with Economic Operators (Suppliers, Distributors, Importers, and Authorised Representatives) Reviewing and approving new Economic Operators in collaboration with Purchasing and Business Development teams Developing quality agreements with Economic Operators alongside Purchasing and Legal Monitoring supplier performance and supporting investigations of non-conforming materials (e.g., SCARs) Leading internal and supplier audits as the site Lead Auditor Supporting Incoming Quality Assurance - raw material specifications, CoA reviews, and visual inspections Participating in external audits (HPRA, Notified Body, Customer) Contributing to NCs, CAPAs, Change Controls, and Document Control Reviewing and approving SOPs, manufacturing documentation, and material control records Maintaining strong housekeeping and compliance with Health & Safety policies Qualifications B.Sc.
in Science, Engineering, QA, or a related field Lead Auditor qualification Minimum 2 years' experience in a quality role, ideally within diagnostics or regulated manufacturing Solid understanding of regulatory standards: FDA 21 CFR 820, ISO 13485, IVDD 98/79/EC, IVDR (EU) 2017/746 Familiarity with ISO Risk Management) Additional Information What's in it for you?
25 days annual leave Health allowance and life assurance Retail discounts (local and national) 24/7 Employee Assistance Programme Recognition & reward schemes Ongoing career development & progression opportunities A supportive culture driven by our values: Passion | curiosity | integrity | brilliance | respect At LGC, we foster a culture of inclusion and collaboration.
We believe that diverse perspectives lead to better outcomes and encourage applicants from all backgrounds to apply.
We are an equal opportunity employer and offer reasonable accommodations to individuals with disabilities.
If you require any adjustments throughout the recruitment process, please let us know.
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