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Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 7,000 employees worldwide. Founded in 1954, Elanco is a division of Lilly. Our worldwide headquarters and research facilities are in Greenfield, Indiana.
The PPM Quality Representative role assures Quality oversight for the development and creation of printed packaging materials artwork. The primary responsibilities include Quality oversight, support and ensuring compliance and control of the PPM business processes and their quality systems along with providing back-up support for the PPM Quality Regional Associates for product launches and MAT (marketing authorization transfer) projects.
Support the development and creation of the PPM global & regional quality systems
Interact collaboratively with PPM staff and QA groups to provide understanding and visibility of PPM oversight model and responsibilities
Accountable to ensure routine, periodic reviews of artwork executed
Review and approve launch related PPM
Ensure compliance to PPM oversight model
Create, manage and provide oversight of the PPM Quality assessment plans
Support routine assessments for both internal and external partners
Manage and provide oversight of the PPM Quality metrics
Manage and provide oversight of the PPM Quality Q Plan
Manage strategic regional project initiatives and drive process improvements
Lead PPM Quality OE initiatives
Review and approve launch related PPM
Recognize and solve problems that occur regarding art work reviews
Provide support and assistance for oversight of art studios and print vendors when needed.
Participate on QA special project teams as required.
Support and provide back-up for Regional PPM Quality Associates as needed for PPM investigations, launches and MAT
Leverage supervision and other known expertise to resolve PPM issues and gain further knowledge of the PPM business
Assure compliance to Quality agreement requirements between Elanco and contract partners
Support PPM Quality project plans to meet business objectives and time lines
Bachelors degree or Associate degree with 5 years of pharma and/or Quality - GMP or HS Diploma/GED with 7 years 5 years of pharma and/or Quality - GMP
3 years of pharmaceutical and /or Quality and GxP experience.
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Experience with printed packaging materials and Animal Health preferred.
Excellent written, oral communication, interpersonal and organizational skills
Effective collaboration and communication skills with various cultures, work styles, and levels
Demonstrated problem-solving skills
Ability to manage a variety of conflicting demands to meet defined goals
Excellent attention to detail and critical thinking skills
Discipline to meet deadlines
This position is not permanent. It is for a fixed duration of two years with potential to extend annually for up to 4 years.
Lilly 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.
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