Boston Scientific Quality Assurance Engineer II 

Ireland, Galway 

715097959

on a

Purpose

• Provide Independent Quality Assurance Support to the Operations Analytical laboratory. Maintains, develops and implements laboratory methodologies, systems and practices. Provide independent guidance to the analytical lab while ensuring compliance to procedure and cGMP requirements.

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.
• Preparation and compilation of Annual Product reviews on DES Products
• Schedule and complete laboratory assessments
• Provide the independent review of NCEP’s and eCAPA
• Review and approval of equipment/ software testing method validation.

What we need from you:

• 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 Analytical background including HPLC experience.
• Strong organizational skills including ability to follow assignments through to completion.
• Detailed knowledge of applicable regulatory requirements.