Quality Consultant

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: Quality Consultant

As a Quality Consultant, you will provide independent quality oversight of Contract Manufacturers (CMs) across the Asia Pacific region.

In this role, you will be responsible for ensuring that manufactured products comply with market authorisations for local and global markets, while proactively managing risks related to product quality, GMP compliance, and animal safety.

You will work closely with internal and external stakeholders to support batch release, stability programs, product quality reviews, and quality event management, primarily supporting the Australia and New Zealand markets.

Your Responsibilities:

Quality Governance of Contract Manufacturers and Products


* Provide quality oversight of contract manufacturers, including recommending and supporting quality improvement initiatives


* Ensure Quality/Technical Agreements are in place with all contract manufacturers and that joint problem-tracking (JPT) processes are implemented for quality or GMP deficiencies


* Participate in inspections and audits of contract manufacturers, including follow-up and verification of corrective actions


* Complete annual contract manufacturer risk assessments

GMP Documentation & Data Integrity


* Develop, review, and approve internal GMP procedures and quality documentation


* Review and approve GMP documentation from contract manufacturers related to assigned products


* Ensure records are retained in accordance with local and global requirements


* Ensure data integrity through second-person verification and/or validated computerized systems


* Review and assess data integrity practices at contract manufacturers to ensure compliance with company standards

Quality Management: Batch Release, Stability & PQR


* Batch Release:
+ Provide disposition decisions for APIs, packaging materials, intermediates, and finished products


* Stability:
+ Manage and monitor internal stability programs
+ Provide oversight of stability programs conducted at contract manufacturers


* Product Quality Review (PQR):
+ M...