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  • Emplois similaires à : Quality Management Rep
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Quality Assurance - External Manufacturing Compliance - Documentation Management100 Eli Lilly and Company • Indianapolis, Indiana, United States
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Quality Assurance - External Manufacturing Compliance - Documentation Management

100 Eli Lilly and Company
  • US
    Indianapolis, Indiana, United States
  • US
    Indianapolis, Indiana, United States
Postuler Maintenant

À propos

External Manufacturing (EM) Quality Assurance assures patients worldwide of safe and efficacious drug products through effective quality oversight of contract manufacturers and alliance partners. The QA Representative will provide oversight into departmental document management systems and data integrity initiatives to ensure compliance with Global Quality Standards, cGMPS, and other departmental documentation. Responsibilities
Serve as the primary point of contact for documentation management across Drug Product External Manufacturing (DPEM), Dry External Manufacturing (DryEM), and APIEM, ensuring seamless coordination and compliance. Serve as the primary liaison between the Learning & Development (L&D) central team and EM, ensuring effective communication, collaboration, and alignment of documentation and training initiatives. Represent the organization in global QualityDocs forums, leading the implementation of key initiatives and fostering cross‑functional collaboration. Champion a culture of continuous improvement and automation within EM documentation practices, proactively identifying and driving process enhancements. Act as the Business Area Representative for EM’s Veeva Quality Documents control groups, providing oversight and maintaining document management and data integrity related SOPs and guidance documents. Design and deliver training sessions on document management systems, empowering team members to maintain up‑to‑date expertise and operational excellence. Ensure that the EM document management system is maintained efficiently and aligned with GMP expectations. Ensure system audit trail reviews are completed for electronic document management systems (EDMS). Support overdue document monitoring for EDMS. Escalate quality or compliance issues through line management, if necessary. Provide support in the preparation (audit readiness) and execution (audit logistics) of internal audits. Support outsourcing activities from a documentation and training set up activities. Participate in the creation and revision of standard operating procedures if necessary. Manage and coordinate GMP Library activities, acting as the SME contact. Basic Requirements
Bachelor’s Degree in a science related field such as Engineering, Pharmacy, Chemistry, Biological Sciences or related Life Sciences. 2+ years of hands‑on experience in a GMP‑regulated pharmaceutical environment, with direct involvement in document control, quality systems, or a related compliance function. Qualified applicants must be authorized to work in the United States on a full‑time basis; Lilly will not provide support for or sponsor work authorization or visas for this role. Additional Skills/Preferences
Proficiency of computer system applications. Previous experience in the pharmaceutical industry. Teamwork and interpersonal skills exhibited across functional areas: technical, leadership, administrative. Ability to work independently. Experience in Lilly electronic quality systems preferred (Trackwise, QDocs, ServiceNow, SuccessFactors). Strong written, verbal, and interpersonal communication skills. Ability to seamlessly balance multiple projects and tasks. Strong attention to detail. Improvement mindset. Additional Information
Shift is days, but off‑hours may be necessary to support operations. Some travel is possible ( Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. EEO Statement
Lilly is a proud EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
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  • Indianapolis, Indiana, United States

Compétences linguistiques

  • English
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