Quality Assurance Specialist for Biopharmaceuticals

7 days ago


Limerick, Limerick, Ireland Eli Lilly and Company Full time

Our Commitment to Quality

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Eli Lilly & Company is dedicated to delivering high-quality biopharmaceutical products to patients around the world. We achieve this through a comprehensive quality management system that ensures compliance with regulatory requirements and industry best practices.

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Job Description:

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We are seeking a skilled Biotechnology QA Sr. Associate to join our quality assurance team. As a key member of our team, you will be responsible for ensuring the quality and regulatory compliance of our biopharmaceutical products.

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Responsibilities:

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- Develop 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 production and QC teams to ensure product quality throughout the manufacturing process.
- Investigate and address deviations, non-conformities, and CAPA to maintain product quality.
- Stay current with industry regulations, guidelines, and best practices.

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Requirements:

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- Bachelor's degree in Pharmacy, Science, Engineering, Quality, or related discipline.
- Minimum of 5 years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment.
- Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management, and other biopharmaceutical regulatory requirements.

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Eli Lilly & Company values diversity and inclusion.

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#WeAreLilly



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