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 work worldwide to discover and bring life-changing medicines to those in need, improve understanding and management of disease, and give back to communities through philanthropy and volunteerism. We are committed to putting people first and making a difference.
Key Responsibilities:
* Ensure proper review and approval or rejection of packaged batches.
* Ensure local application of GMP and applicable corporate standards.
* Support the packaging area with incidents, projects, etc.
* Serve as the contact point for packaging process-related quality management.
* Recommend and initiate quality improvements in operational areas and advise the Quality Assurance Manager or other responsible parties on issues and improvements.
* Ensure compliance with investigation/review and approval objectives related to deviations, changes, complaints, or corrective actions.
* Collaborate in the annual evaluation program of products and packaging in the plant, following established procedures and standards.
* Approve GMP documents for the plant to ensure compliance with standards, including procedures, specifications, validations, qualification protocols, and reports.
* Manage and approve, as applicable, changes related to the packaging area.
* Ensure communication of significant quality issues to the Operations Quality Assurance Manager or other Quality Unit responsible.
* Assist in external audits conducted by official agencies, the corporation, or contracted manufacturers.
Educational Requirements:
University degree in Health Sciences (Pharmacy, Chemistry, Biology).
Language Requirements:
Fluent spoken and written English (C1 level).
Work Shift: Afternoon shift, Monday to Friday.
Previous Experience:
Minimum 2 years of experience in technical areas within a pharmaceutical plant.
Personal Skills:
* Interpersonal skills: teamwork, customer orientation (internal/external), decision-making, good oral and written communication.
* Organizational skills: ability to prioritize objectives.
* Technical skills: knowledge of Good Manufacturing Practices, quality concepts, and their application in the pharmaceutical industry.
* Computer skills: proficiency in common office software and familiarity with systems controlling business processes.
Lilly is committed to helping individuals with disabilities actively participate in the workforce and ensuring equal opportunities. If you need accommodation to submit your application, please complete the workplace accommodation request form. Lilly does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected status.
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