Analytical Quality Specialist – Galway

  • Reference: GY46708
  • Job Type: Contract
  • Location: Galway
  • Category: Science, Pharmaceutical & Food

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.

Responsibilities:

  • 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 a confidential discussion and more information on the role/company please email your CV to: amy.oneill@collinsmcnicholas.ie


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Amy O’Neill

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