Our client, a medical device company in Galway is currently looking to recruit an Analytical Quality Specialist for their site.
The Analytical Quality Specialist provides performs a variety of QA review/approval functions and provide quality assurance for the Analytical Chemistry and Product Release areas to ensure compliance to internal procedures and external regulatory standards before the final product reaches the customer.
- Provides quality assurance support and direction to the Analytical Laboratories responsible for the testing and release of all drug combination products and raw materials used on the site, utilizing paper and electronic LIMS systems with minimal or no supervision.
- Provide quality oversight to support software/equipment validation and test method validations/transfer projects for the Analytical Laboratories.
- Assist in Audits/tests of ongoing processes to assure continued compliance.
- Assists in laboratory investigations, both from technical and compliance perspective.
- Perform collection, analysis, and trending of quality indicator data in support of management review and/or laboratory goals and objectives.
Education/Qualifications & Experience
- Analytical skills, Problem-solving and decision-making skills and Thoroughness
- Level 8 Qualification in science or related engineering discipline.
- Minimum of 3-5years in a similar role.
- Excellent written and verbal communication skills.
- Experience working with dynamic cross functional teams and prove abilities in decision making.
- Strong organisational skills including ability to follow assignments through to completion.
- Detailed knowledge of applicable regulatory requirements.
For further information on this Analytical Quality Specialist role in Galway please contact Clara Burke on 086 8168273 / firstname.lastname@example.org
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