Senior Quality Associate Elanco External Manufacturing

Senior Quality Associate Elanco External Manufacturing focuses on maintain improvements in the quality systems and processes, related to 3rd party manufactures, suppliersand logistic service providers.

What the role involves

• Maintain improvements in the quality systems and processes, related to 3rd party manufactures, Suppliersand Logistic Service Providers.
• Supporting the qualification and onboarding of Third Parties and Logistics Service Providers in line with GMP/GDP and global quality standards.
• Provide Quality input for product launches, qualification, and validation activities.
• Support change controls with external partners and internal stakeholders.
• Supporting regulatory submissions and GDP inspections.
• Maintaining and implement Quality Agreements with suppliers and logistics partners.

Skills and requirements

• Degree in Science (Diploma, Master’s degree or equivalent) or minimum 10 years equivalent experience in GMP role.
• Minimum 5 years’ experience in Quality Assurance within Distribution GDP regulated environments.
• Strong knowledge of GMP, GDP, and regulatory requirements for medicinal products.
• Experience working with external manufacturers, suppliers, or distribution partners.