Telephone: 086 3073779
Analytical Quality Specialist
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 Operations Analytical and Product Release areas to ensure compliance to internal procedures and external regulatory standards.
- Provides quality assurance support and direction to the analytical laboratory responsible for the testing and release of all drug combination products and raw materials used on the site.
- Responsible for ensuring that Raw Materials, Finished Goods, non-routine and Stability testing is carried out in accordance with cGMP both in BSC laboratories and at the contract laboratories.
- The QA Specialist shall provide support and guidance in the areas of cGMP, Compliance, Regulatory, and Technical Investigation.
- The role also requires working with the cross functional groups including Product Release, Supply Chain Planning, Shipping and Distribution groups.
- Level 8 Qualification in science or related engineering discipline. Minimum of 3-5years in a similar role.
- Experience working in the pharmaceutical or biotechnology industry is essential.
- 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 Deirdre Finnerty on 086 3073779 / firstname.lastname@example.org
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