Senior Associate
2 days ago
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
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. We are seeking a highly motivated and detail-oriented Senior Quality Engineer to join our quality assurance team supporting our facilities, cleaning, and utilities and ensure the highest standards of product quality and compliance.
Position Summary: As a Senior Quality Engineer, 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:
1. Quality Assurance Oversight:
- Influence and oversee Commissioning and Qualification (C&Q) of GMP assets including review and approval of associated deliverables (protocols, drawings, test documents, etc.).
- Develop and maintain quality assurance procedures, policies, and systems.
- Conduct routine self-inspections and monitoring assessments to ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulations.
- Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions).
2. 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.
3. Documentation and Reporting:
- Maintain accurate and comprehensive quality records, including procedures, qualification documentation change control documentation, and quality reports.
- Prepare and review documentation related to product quality and compliance including GMP standard operating procedures, process flow documents as well as equipment qualification and process validation documentation.
4. 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.
5. Training and Development:
- Provide training to staff on quality-related procedures and best practices.
- Stay informed about the latest developments in biotechnology and quality assurance.
Qualifications:
- BSc, Hons BSc, MSc, or PhD in Pharmacy, Science, Engineering, Quality, or related discipline.
- Minimum of 3-5 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 (e.g., TrackWise, GMARS), experience within or supporting pharmaceutical utilities and facilities, facility qualification, and cleaning validation programs are a plus.
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