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Quality Assurance Associate
hace 4 meses
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.
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.
Position Name
Quality Assurance Associate / Sr. Associate
What is the day-to-day life of this position like?
Reviewing and approving quality assurance-related documentation, such as certificates of analysis and import records.
Investigating and documenting quality deviations, non-conformities, and customer complaints, identifying root causes and recommending corrective actions.
Keeping up to date the processes of management and monitoring of GMP/GDP suppliers, management of product complaints.
Providing support in the launch of new products from the market and the process of product withdrawals.
Collaborating in building a strong communication channel with the Affiliate's leading teams and local management by participating in relevant business meetings to ensure the timely integration of the Quality Assurance area among the Affiliate's operations.
Escalating major product quality issues to regional/global quality and business management and determining urgently the impact of quality issues or failures on products, with special attention to those that may impact the safety of patients or produce a recall.
Participating in product quality GXP audits as required.
This role will report to the Qualified Person (Responsable Sanitario)
This position is for you if:
You are a Bachelor of Pharmacy, Pharmaceutical Chemist Biologist (QFB) or Industrial Pharmaceutical Chemist (QFI). Bachelor of Pharmacy (LF), Pharmaceutical Chemist Biologist (QFB) or Industrial Pharmaceutical Chemist (QFI). A minimum of 1 year's experience in quality assurance applied to the pharmaceutical industry is desirable. You have knowledge and mastery of Mexican regulations (NOM059, FEUM Supplement - Warehouses), Good Manufacturing Practices (GMP), Distribution (GDP), as well as applicable regulations (FEUM, USP, Ph. Eur, etc.). Youa re able to show proficiency in the English language at least B1 and Office 365. to start working. You must have work permissions in Mexico and Immediate availability.
What skills are we looking for?
-Ability to concentrate, organize, plan, prioritize and negotiate.
-Teamwork and results-oriented
-Excellent interpersonal relationships
-Outstanding abilities in both oral and written communication
-Ability to analyze quality data and trends, identifying areas for improvement.
-Critical Thinking and Problem Solving
What we offer:
-Work for the #1 pharma company in value and #9 company worldwide regarding market cap and stock price.
-Work for the 3rd best company in Mexico according to Top Companies
-We cultivate a dynamic, motivating, and respectful work environment where employees achieve a balance between work and personal life,
-Flexible hours and hybrid mode (Mondays and Fridays working from home, and Tuesdays to Thursdays in the office).
-Access to a gym, dining area, and parking.
-Benefits superior to those required by law.
Most important of all, we are looking for a person who wants to join our promise to make life better for people around the world
#WeAreLilly
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 ( *************** ) 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.
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 ( *************** ) 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.
#WeAreLilly