Quality Assurance Specialist

3 days ago


Dublin, Dublin City, Ireland Eli Lilly And Company Full time

At Eli Lilly And Company, we are dedicated to making life better for people around the world by discovering and developing innovative medicines. We're seeking a highly skilled Quality Assurance Specialist to join our team in Dublin, Ireland.

About the Role

This is an exciting opportunity to work on-site at a Contract Manufacturer (CM) site in Dublin, Ireland, providing daily quality oversight and ensuring compliance with cGMP requirements and regulatory standards. As a Quality Assurance Specialist, you will be responsible for providing guidance and support to the CM team, reviewing batch records, and identifying potential issues. You will also be working closely with cross-functional teams to ensure timely resolution of product-related issues.

Key Responsibilities
  • Provide quality oversight and guidance to the CM team
  • Review batch records and identify potential issues
  • Work closely with cross-functional teams to resolve product-related issues
  • Ensure compliance with cGMP requirements and regulatory standards
  • Support the development of quality systems and processes
Requirements
  • Bachelor's Degree in Pharmacy, Chemistry, Engineering, Biological Science, or related Life Science
  • Minimum 3-5 years of experience supporting quality and/or technical functions within Device Assembly/packaging operation
  • Regulatory-related experience and knowledge of cGMPs and Global Quality Standards
  • Strong written and communication skills, especially attention to detail in written procedures and protocol development
  • Able to represent Eli Lilly's mission, policies, and practices in a positive, professional, and ethical manner


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