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 35,000 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.
1. Responsible for complying with the Corporate and Local quality policies.
2. Responsible for Quality Assurance in the Quality Control Laboratory.
3. Evaluate compliance with validations and / or analytical transfers of chemical and microbiological analysis methods.
4. Evaluate the correct development of standard operating procedures.
-Ensure compliance with corporate standards and policies in good documentation practices and data integrity for the entire Laboratory.
-Provide Data Integrity training to all Laboratory staff as well as Southern Cone Affiliates and Alliance Partner Laboratories.
-Ensure that computerized systems are validated in compliance with Corporate standards and policies for computerized systems and maintain them throughout their life cycle.
-Generation of Control Change inherent to the Quality Control laboratory.
-Approval of laboratory deviations considered “Deviation Observation” as described in GQS104- Deviation Management.
-Participation in daily meetings to investigate root causes related to findings made in the Quality Control laboratory.
-Review all required analytical methods and specifications and update them in the Regulus Central 22/Quality Docs system.
-Ensure that SOPs are updated and uploaded to the Quality Docs system
-Participate in transfers and analytical verifications of new and current products as needed. Participate in the support of the analytical training method for new analysts.
-Prepare Laboratory metrics reports, e.g. Tableau Metrics
-Execute the Qualification Master Plan, ensuring that all qualifiable equipment is within the annual QMP. And every year end to close on time the QMP reporting any deviation, delay or problem that has occurred in the qualification or calibration of any equipment.
-Carry out an internal audit at least annually of the QC Lab and monitor the action plans on the observations made.
-Records retention management.
-Carry out a QA holistic review of the local Analytical Certificate of each imported product.
• Strong qualities of verbal and written communication, excellent interpersonal skills and systems management, ability to organize and prioritize multiple tasks, ability to work independently, make decisions, be detailed, computer applications, statistical analysis and problem solving.
• Great knowledge of Quality, present a good understanding of cGMP policies, procedures and guidelines.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.