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Analytical Quality Specialist

Job Title: Analytical Quality Specialist
Contract Type: Permanent
Location: Galway
REF: 95178
Job Published: 5 months ago

Job Description

Contact: Deirdre Finnerty
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.

Job Purpose:
  • 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.
Education/Qualifications & Experience:
  • 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 /

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