Quality Coordinator - #7512388

Are you ready for a life-changing career at Novo Nordisk Mexico? Join us.

Working at Novo Nordisk is never just a job, it is an opportunity to have a life-changing career – you grow professionally, and you impact the lives of our patients for better. Our Mexico affiliate is looking for a talented Quality Coordinator.

We invite you to join Novo Nordisk México, a successful affiliate and market leader that is focused on improving the quality of the life of people with Diabetes, Obesity, Hemophilia and Growth Hormone Disorders.

Position:

Ensure activities to maintain and improve Novo Nordisk Quality Management System (QMS), and to fulfill the Novo Nordisk’s and Local Health Authority’s requirements for products and processes. Coordinate and oversee related activities between storage and distribution partners, authorized third-party laboratories, and Novo Nordisk Supply Chain team, to ensure compliance of Good Storage and Distribution Practices in Mexican territory.

Responsibilities:

In regards of QMS

• Implement quality assurance strategies, processes, and systems to ensure compliance with internal and regulatory requirements incl. GxP requirements
• Interact cross functionally throughout the affiliate to improve and maintain the QMS, by driving simplicity and robust processes.
• Provide QA guidance to ensure quality compliance solutions to innovative business models.
• Perform audits of internal processes and critical suppliers to assure compliance with regulatory requirements, internal standards, and/or service level agreements.
• Subject Matter Expert for deviations, change controls and document control.
• Ensure GxP training and compliance of affiliate QA KPI’s.

In regards of GDP

• Oversee the proper implementation of Good Storage and Distribution Practices and Quality Agreement requirements whitin Logistics Partners.
• Ensure adequate communication with Logistics Partners with respect to operation, internal and regulatory requirements; as well as any situation related to the product.
• Ensure proper and on-time QA disposition of imported and returned products.
• Ensure cold storage conditions are meet and documented throughout product lifecycle.
• Review and approve applicable validation and qualification documents.

Qualifications:

• Bachelor's degree in Pharmacy, QFB or QFI is required
• At least 5 years of experience in Quality Assurance implementing and maintaining quality management systems in the pharmaceutical industry is required.
• Experience in Good Storage and Distribution Practices focused on handling of cold chain products is mandatory for this role.
• Internal and external Quality Audits
• Experience across Health Authority (COFEPRIS) requirements NOM-059-SSA1-2015, NOM-072-SSA1-2012, FEUM and its supplements.
• Fluency in English- Advanced level is required
• Communication and agile skills, adaptability.

About the department:

You will become part of the Mexican team of one of the top pharmaceutical companies in the entire world, with a Danish spark and its own Mexican magic. What defines us is our commitment, passion, creativity, and innovation, which make the perfect blend to reach our goals as a whole team with a unique vision: Change people lives. As the Great Place to Work No. 1 company we are, we can say that there is nothing we seek that we are not willing to achieve.

Welcome to your life-changing career

Working at Novo Nordisk

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world, and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us! Together, we go further.

Together, we're life changing

Contact:

Deadline

Apply before May 17th 2024

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.