At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

BASIC QUALIFICATIONS

• Bachelor´s Degree in Pharmacy, Chemistry, Engineering, Biological Science or related Life Science or equivalent experience.
• Minimum 3-5 years of experience supporting quality and/or technical functions within aseptic manufacturing.

ADDITIONAL SKILLS/ PREFERENCES

• Regulatory related experience.
• Established technical, quality, and internal networks.
• Experience with Lilly systems (SAP, Trackwise, Q docs…etc.).
• Previous experience supporting batch release for parenteral and/or packaging products may be preferred.
• Ability to represent Eli Lilly’s mission, policies, and practices in a positive, professional, and ethical manner and to influence CMs.
• Demonstrated ability to work independently.
• A thorough understanding of cGMPs and Global Quality Standards.
• Strong written and communication skills, especially attention to detail in written procedures and protocol development.
• High learning agility.
• Strong leadership, interpersonal and teamwork skills, able to work effectively in a cross functional team environment.
• Ability to organize, prioritize, multi-task and influence others.
• Ability to influence CM and guide them through Lilly principles
• Strong decision making and problem-solving skills.
• Willingness to learn new technologies.
• Capability to work in a virtual and complex environment.
• Willingness to travel.
• Appreciation for cultural diversity.

This role is responsible for providing daily quality oversight at the Contract Manufacturers (CM) site. This role is located in person on site at the CM site the majority of the time and will support the processes for aseptic manufacturing at the CM. The responsibilities include providing assistance, and guidance during routine manufacturing to issues such as deviation investigations, change control proposals, procedure/ master formula revisions, and other duties associated with daily Contract Manufacturers (CM) activities.
QA Person in Plant may be also responsible for disposition of manufactured drug product batches. This role serves as DPEM QA primary contact to the CM for initial escalation and works with the JPT to ensure timely response for requests for information. They also ensure that batches meet specifications, are manufactured in accordance with validated processes and are compliant with cGMP requirements and regulatory requirements.