Lilly Consultant - Computer Systems Quality Assurance in Indianapolis, Indiana
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.
The CSQA (Computer Systems Quality Assurance) consultant provides support to Parenteral Products production, while maintaining quality systems and GMP compliance. The CSQA Consultant provides primary support to Facility / Utilities / HVAC process teams and the IDS functional group, providing assistance and mentorship in non-conformance investigations, design, construction, equipment and computer systems, change control proposals, procedure revisions, GMP drawings, validations, and commissioning and qualification. The CSQA Consultant’s position is crucial for maintaining GMP compliance and in the preparation for pre-approval and general inspections by various regulatory agencies.
Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals
Support Utilities / HVAC process teams, as outlined in MSOE standard
Influence and lead all aspects of the Commissioning and Qualification (C&Q) and Computer Systems Validation (CSV) of GMP assets, including impact assessment of testing discrepancies
Influence and coordinate Maintenance / Calibration programs within Indy Parenteral, including benchmarking with other sites
Support process team projects and communicate impact to operational areas and associated support groups
Perform approvals for Critical Alarm Audits, Utilities Reports, and Business Reviews
Redline, review, and approve GMP documents / drawings
Perform audit trail review approvals and advise on data integrity concerns
Coach and mentor others in aspects of fundamental CSQA support, including process knowledge, problem solving, project management, and documentation design
Assist in self-led and / or agency inspections
Evaluate possible product quality impact for any GMP-related incident, perform initial leveling of non-conformances, and support the investigations
Bachelor of Science Degree in Automation Engineering, Computer Science, or equivalent experience (i.e., 5+ years of experience in Automation / IT or computer system validation)
Demonstrated experience in a GMP facility
Proficiency with IT systems development life cycle
Proficiency with Computer Systems Validation (CSV) and ability to right-size validation based upon risk
Technical proficiency with Microsoft Office, EDMS, SQL, TrackWise, SAP, etc.
Demonstrated strong communication and interpersonal interaction skills, and ability to influence others and collaborate
Previous experience with Lilly deviation and change control process
Experience in Production, Automation Engineering, QC, QA, or IDS preferred
Knowledge of cGMP's
Demonstrated technical writing and written communication skills
Overtime may be required.
May be required to support off shift activities related to operational issues
Applicant may work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
May be subject to Post Offer Exam
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