Quality Systems Specialist

LGC is a world-class Clinical Diagnostics company committed to improving patient healthcare. We are looking for a motivated and ambitious Quality Systems Specialist to join our growing QA team in Ballina. This is a fantastic opportunity for someone early in their quality career who wants to develop into a future QA Specialist.
To perform this job successfully, an individual must be able to capably perform each of the following essential functions:
Duties:
Implement, maintain and continuously improve applied quality system approach at Technopath Manufacturing Business.
Manage process for control of Economic Operators to TCD (Suppliers / Distributors / Importers / Authorised Reps).
Liaise with the Purchasing & Business Development groups to identify new Economic Operators as needed. Review suitability of new Economic Operators in accordance to established quality system requirements and approve for use if all require criteria have been achieved.
Collaborate with Purchasing and Legal to ensure the development and implementation of effective quality agreements with Economic Operators.
Monitor existing Economic Operators’ performance on a routine basis.
Communicate with Economic Operators regularly. Establish and develop good working relationships with Technopath Economic Operators.
Support the assessment of non-conforming raw materials received from suppliers. Liaise with Quality Systems to ensure the effective completion of Supplier Corrective Actions (SCAR's)
Conduct Economic Operator quality control audits as required to ensure vendors and their supplies remain in compliance with company requirements and regulatory standards.
Support Incoming Quality Assurance: Maintain raw material specifications (file/update), complete check of raw material certificates of analysis, perform visual inspections.
Coordinate, execute and lead the auditing program by conducting internal audits as well as supplier quality audits as the site Lead Auditor.
Support and participate in external Audits (HPRA, Notified Body Audit, Customer Audits)
Provide support to Non-Conformance, CAPA, Change Controls and Documentation Control activities as required.
Update, review and approval of quality documentation such as SOPs, Material control records, Manufacturing Documentation etc.
Perform other duties as required to support Technopath Manufacturing Quality Systems (QA, RA, Quality Support)
Operate within the company’s standard operating procedures and review, maintain and create appropriate procedures.
Ensure compliance with internal procedures and regulatory requirements for the secure handling, storage, documentation, and accountability of controlled drugs, as applicable to the role.
Maintain a good level of housekeeping in designated areas and observe all Health and Safety at work requirements.
B.Sc. in Science/Engineering/QA or related discipline.
A minimum of 2 years practical experience required in a quality function.
Thorough knowledge of FDA 21CFR820, ISO13485, IVDD98/79/EC, IVDR (EU) 2017/746 and international regulatory requirements.
Familiar with ISO 14971.

Employment type
Full-time

Work arrangement
No