Assistant Manager QA

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.

We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

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!

As the Assistant Manager Quality Assurance for the Elanco external manufacturing (EEM), the responsibility is providing quality oversight of assigned contract manufacturing organizations (CMOs) and suppliers within Elanco’s network in India.

The primary responsibility of this position is to ensure the CMOs are compliant with relevant regulations and Elanco requirement, thereby ensuring products released to market are fit for intended use and meet all legal and Elanco requirements.

As Assistant Manager QA, you need to drive and maintain improvements in the quality systems and processes, at CMOs, suppliers, and to provide advice on all quality and compliance matters.

Responsibilities/ Duties/Tasks:


* Ensure that all marketed products are dispositioned in accordance with local regulations and Elanco requirements


* Drive the utilization of Quality Risk Management principles for contract manufacturing sites


* Ensure Quality activities of pharmaceutical products at identified CMOs to comply with the requirements of the Elanco Global standards and meet all relevant cGMP & regulatory requirements


* Manage and support change control, deviation, non-conformance and market complaint investigation at Elanco and contract manufacturing sites


* Manage Quality agreements with contract manufacturing site.


* Support and provide quality input for Qualification and validation activities at CMOs and product launches


* Management of Product Quality Reviews (PQR) of CMOs- Review of PQR, corrections/follow-up actions & monitoring of PQR trends


* Schedule and follow up on audits at contract manufacturing sites and suppliers and monitor the corresponding corrective actions in line with Elanco Global Compliance and Auditing team requirements/timelines


* Implement continuous improvement initiatives, quality management review and governance associated with quality system to ensure they are both robust and effective and enable appropriate levels of supplier monitoring and product quality performance


* Review of analytical data, c...