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Manufacturing Execution System

1 week ago


Limerick, Limerick, Ireland Eli Lilly and Company Full time

About Us

Eli Lilly and Company is a cutting-edge biotechnology company dedicated to revolutionizing the healthcare industry through the development and production of next-generation biopharmaceuticals. Our state-of-the-art manufacturing facility in Limerick, Ireland is at the forefront of innovation, employing the latest bioprocessing technologies to create life-saving therapies.

Job Description

We are seeking a highly motivated and detail-oriented Senior Associate to join our quality assurance team at our next-generation manufacturing facility in Limerick, Ireland. As a Manufacturing Execution System (MES) Quality Sr. Associate, you will play a critical role in maintaining the quality and regulatory compliance of our biopharmaceutical products. You will work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.

Responsibilities:

  • Implement and maintain quality assurance procedures, policies, and systems.
  • Conduct regular self-inspections and monitoring assessments to ensure compliance with cGMP and other relevant regulations.
  • Collaborate with automation, IT, and production teams to ensure quality throughout the manufacturing process.
  • Investigate and address deviations, non-conformities, and CAPA to maintain quality associated with MES quality events.
  • Stay up-to-date with industry regulations, guidelines, and best practices.
  • Support the preparation and execution of regulatory inspections and audits.

Requirements:

  • Bachelor's degree in a relevant field.
  • Minimum of 3 years of experience in quality assurance within a biotechnology, pharmaceutical, or medical device manufacturing environment.
  • Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management, and other biopharmaceutical regulatory requirements.
  • Excellent problem-solving and analytical skills.
  • Detail-oriented with a strong commitment to maintaining high-quality standards.