Regulatory Compliance Expert

1 week ago


Limerick, Limerick, Ireland Eli Lilly and Company Full time

We are Eli Lilly and Company, a global leader in healthcare, dedicated to making life better for people around the world. We are seeking a highly skilled and detail-oriented Senior QA Professional to join our quality assurance team in Biotechnology Operations.

About Our Company:

We operate in a fast-paced and dynamic environment, where collaboration, creativity, and innovation are valued. Our culture emphasizes respect, open communication, and inclusivity, providing opportunities for growth and development.

Job Overview:

This role will be responsible for ensuring the quality and regulatory compliance of our biopharmaceutical products within our next-generation manufacturing facility. The successful candidate will work closely with cross-functional teams to develop and maintain quality assurance procedures, policies, and systems.

Main Responsibilities:

  • Quality Assurance Oversight:
  • Develop and maintain quality assurance procedures, policies, and systems to meet regulatory requirements.
  • Conduct routine 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.
  • Regulatory Compliance:
  • Stay current with industry regulations, guidelines, and best practices.
  • Assist in the preparation and execution of regulatory inspections and audits.
  • Ensure that all products meet regulatory requirements, including documentation and reporting.

Requirements:

  • BSc, Hons BSc, MSc, or PhD 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.
  • Excellent problem-solving and analytical skills.
  • Detail-oriented with a strong commitment to maintaining high-quality standards.
  • Effective communication and teamwork skills.
  • Demonstrated initiative – able to work proactively without direct supervision and with a continuous improvement mind-set.
  • Experience with quality management systems is a plus.


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