Senior Associate – Quality Assurance for Manufacturing Execution System

Job title:

Senior Associate – Quality Assurance for Manufacturing Execution System

Company

Eli Lilly

Job description

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.Job Title: Senior Associate Quality Assurance for Manufacturing Execution SystemLocation: Initial 6-9 month secondment in Kinsale, Cork, Ireland, then moving permanently to Raheen, Limerick, Ireland (Full-time on site)Company: Eli Lilly & CompanyAbout 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 QA Sr. Associate to join our quality assurance team and ensure the highest standards of product quality and compliance for our electronic batch records and associated Manufacturing Execution Systems (MES).Position Summary: This role will involve an initial 6-9 month secondment in Lilly Kinsale in order to gain hands-on experience and training at an established site prior to transitioning permanently to Lilly Limerick. As a Manufacturing Execution System (MES) Quality Sr. 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:1. Quality Assurance Oversight for MES:

• 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 associated with MES quality events.

• Participate in IT, production, and process automation organizations to provide consistency across all manufacturing execution systems.

2. 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 and archive, security, and other support processes for MES.

3. Documentation and Reporting:

• Maintain accurate and comprehensive quality records, change control documentation, and quality reports.

• Develop common local procedures for MES and support review and approval of GMP documents associated with qualification and validation for MES.

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:

• Communication and education of personnel in GMP requirements and regulations related to MES

• Stay informed about the latest developments in eBRs and quality assurance.

Qualifications:

• BSc, Hons BSc, MSc, or PhD in Science, Engineering, Quality, or related discipline.

• Minimum of 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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.Lilly does 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.#WeAreLilly

Expected salary

Location

Limerick

Job date

Tue, 07 Jan 2025 23:36:20 GMT

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