About Us: Eli Lilly Limerick 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 is at the forefront of innovation, employing the latest bioprocessing technologies to create life-saving therapies.
Job Title: Senior Associate QA
Position Summary: As a Senior Associate, you will play a critical role in maintaining the quality and regulatory compliance of our biopharmaceutical products within our next-generation manufacturing facility. You will work closely 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.
* Regulatory Compliance: Stay current with industry regulations, guidelines, and best practices. Assist in the preparation and execution of regulatory inspections and audits.
* Documentation and Reporting: Maintain accurate and comprehensive quality records, change control documentation, and quality reports.
* Quality Improvement Initiatives: Identify areas for process improvement and work collaboratively with cross-functional process teams to implement changes.
* Training and Development: Provide training to staff on all relevant aspects of computer system quality.
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.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. We do not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.