Our client, a leading global healthcare company based in Sligo, is seeking to hire a Quality Specialist on an initial ten-month contract. The successful individual will conduct quality-related activities such as preparing compliant documents & records; review & approval of quality records, product labels and product specification documents; and will help to support implementation of NPD projects and management of third-party manufacturers (TPMs).
Responsibilities of a Quality Specialist (Full job description available on request):
1. Collaborate with colleagues in Technical, Regulatory, Planning, Engineering and Operations to perform product changes, non-conformances, quality agreement revisions, product/process improvements & product launches.
2. Build effective working relationships with Third Party Manufacturers (TPM) and globally based colleagues to enable successful problem solving and issue resolution.
3. Contribute to and ensure timely achievement of overall New Product Development project goals and tasks.
4. Support transition of TPM products to meet IVDR regulation
5. Support External and Internal audits of sites responsible for TPM products.
6. Ensure compliance to global policies and procedures through creation of compliant records and documentation.
7. Review multiple data sources and records at the same time, to identify GAPs and follow leads to investigate solutions. Helps to provide GAP analysis, data sets and justifications in support of change.
Ideal background:
8. 3rd level qualification in Life Science, Pharmaceutical Science, Quality or closely related discipline OR relevant combination of education and experience.
9. 1-2 years' experience working in Quality, Technical or a related field in commercial cGMP health care facility. Less experience may be considered based on degree level and grades.
10. Experience in NPD, design transfer or assay method development projects within Device or Pharma industry would be highly advantageous.
11. Ability to work independently, with globally based colleagues and with minimal management oversight.