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Quality Assurance - Computer Systems

Eli Lilly and Company
Full-time
On-site
Lebanon, IN
$65,250 - $169,400 USD yearly

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Role Summary

Quality Assurance - Computer Systems at Lilly, focused on overseeing computer system validation at the Lebanon API Manufacturing facility. Develop validation strategies compliant with corporate standards, maintain standards and practices, participate in inspections, and drive continuous improvement in CSQA/CSV processes.

Responsibilities

  • Deliver on CS processes: Establish and maintain CSQ support and sustainability processes.
  • Deliver Projects and Programs: Understand customer, company, and Quality priorities, and support implementation goals; link CSQA/CSV with Automation/Engineering, Site Equipment Verification, Business QA, and other CSQA persons.
  • Grow Capabilities and Knowledge: Mentor others in CSQA / CSV-related roles.
  • Maintain Inspection Readiness: Provide consulting and interpretation on Corporate Computer Systems/Data Integrity standards; lead cross-functional technical responses to serious quality issues; monitor inspection-readiness; escalate issues as needed.
  • Streamline and Continuously Improve: Promote common processes and best practices; identify systemic issues and drive improvement; apply external learning.

Qualifications

  • Required: Bachelor’s degree in computer science, Engineering, Life Sciences, or a technology-related field OR 10+ years of relevant experience; 3+ years of experience in Automation/QC Labs/IT, Quality, or computer system validation in the pharmaceutical industry.
  • Preferred: Direct experience with Computer Systems Validation (GAMP5) and data integrity principles (ALCOA+); experience validating automation systems (DeltaV, PLCs); GMP production environment experience; strong communication and interpersonal skills; ability to influence peers and management; experience in Business Quality Assurance and Automation.

Skills

  • Computer Systems Validation (CSV)
  • Data Integrity (ALCOA+)
  • GAMP5 framework
  • Automation/Engineering collaboration
  • Quality Assurance and regulatory readiness
  • Communication and stakeholder influence

Education

  • Bachelor’s degree in computer science, Engineering, Life Sciences, or related field (or equivalent experience).

Additional Requirements

  • On-site position in Lebanon, IN.
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