Lilly is a global healthcare leader dedicated to making life better for people around the world. We give our best effort to our work, and we put people first.
About Us
Eli Lilly Limerick is a cutting-edge biotechnology company that revolutionizes the healthcare industry through next-generation biopharmaceuticals. Our state-of-the-art manufacturing facility employs the latest bioprocessing technologies to create life-saving therapies.
Position Summary
As a Senior Associate, you will play a critical role in maintaining quality and regulatory compliance of our biopharmaceutical products within our next-generation manufacturing facility. You will work with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.
Key Responsibilities:
* Quality Assurance Oversight:
• Develop and maintain quality assurance procedures, policies, and systems.
• Conduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP (current Good Manufacturing Practices) 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 (Corrective and Preventive Actions) to maintain quality.
• Participate in IT and process automation organizations to provide consistency across all computer systems areas.
* Regulatory Compliance:
• Stay current with industry regulations, guidelines, and best practices.
• Assist in the preparation and execution of regulatory inspections and audits.
• Ensure compliance with periodic review, change control, deviation, back-up, archive, security, and other support processes for systems.
* Documentation and Reporting:
• Maintain accurate and comprehensive quality records, change control documentation, and quality reports.
• Develop common local procedures for Computer systems and help the site consistently interpret and implement global policies across all computer systems areas.
* Quality Improvement Initiatives:
• Identify areas for process improvement and work collaboratively with cross-functional process teams to implement changes.
• Participate in risk assessments and quality improvement projects.
* Training and Development:
• Provide training to staff on all relevant aspects of computer system quality.
• Stay informed about the latest developments in computer systems validation and quality assurance.
Qualifications:
* BSc, Hons BSc, MSc, or PhD in Science, Engineering, Quality, or related discipline.
* 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.
* 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 (e.g., TrackWise) and automation systems (e.g., DCS, DeltaV) is a plus.