At Elanco (NYSE: ELAN) – it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today!
Your role:
To support third party quality operations at EEM EMEA and ensure that third party products are produced and released according to Elanco requirements. To operate and maintain quality systems which monitor the compliance of third party manufacturers and products.
Your responsibilities:
- To perform QA oversight on assigned external suppliers and third parties manufacturing product for Elanco and ensuring, that the delivered products comply with Elanco quality standards and legal requirements.
- To monitor third party KPI’s to proactively detect and notify to QA management any compliance issue on supplier level that would risk supply of products.
- To review and assess external customer complaints in the global Elanco complaint system, including Root Cause Investigation correctness, product impact assessment, trend/recurrence evaluation, and proposed CAPA assessment, within the due time periods.
- To review and assess Third-Party deviation reports for correctness/completeness, including Root Cause Investigation, assessment of product impact, trending/recurrence evaluation, and suggested CAPA.
- To review batch release documentation provided by third parties to support or act as Authorized Person for release of products for shipment including material status change in SAP.
- To review Third Party Product Quality Reviews (PQR) for quality trends on supplier level including the implementation of necessary corrective actions and provide the Third Party QA Manager with a conclusive summary as base for his final review.
- To overview and request timely annual Pharmacovigilance statements for PQRs.
- To utilize established QA systems for the QA oversight of external suppliers and contractors and ensure that relevant quality agreements are current and in place, supplier risk assessments are periodically performed and Product Quality Reviews (PQR) meet expectations.
- To support QA management in any quality related matter.
- To represent the quality function within Elanco EEM and to give QA support in assigned projects and expert teams
What You Need to Succeed (minimum qualifications):
- Minimum 5 years experience in quality operations in the GMP environment;
- Excellent command of English, other languages are an asset;
- Knowledge and understanding of regulatory requirements;
- Good knowledge in office tools (e.g. Word, Excel, SAP).
What will give you a competitive edge (preferred qualifications):
- Scientific Degree or an equivalent in Chemistry, Biology, Pharmacy or Pharmaceutical Engineering; or equivalent experience
- Experience in customer complaint handling;
- Experience in the negotiation QA contracts;
- Experience in QA systems that support Third Party management;
- Working experience within a global organization
Additional Information:
- Direct reports: none
- Travel: n.a.
Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco is an EEO/Affirmative Action Employer and 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
