Concord IDS Analyst (CSV)

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 35,000 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.

• This role will be responsible for the implementation of the DI culture and strategy for site IDS ensuring compliance with global and local regulatory requirements for systems used at the site (both local and global).
• Coordinate the technical evaluation with site IDS subject matter experts (SMEs) of new and existing systems from a DI and CSV perspective.
• Provide CSV consulting and assist with articulation of CSV needs to the CSV third party service provider(s).
• Lead the implementation of technology solutions across the site to improve DI /CSV compliance.
• Collaborate internally and externally to establish best practices and evaluate new points of consideration to improve technology use at the site.
• Partner with the Site Data Leader and site IDS leadership to lead the gap analysis and remediation efforts of policies associated with DI/CSV related to Good Documentation Practices (GDP) and CSV.
• Represent site MQ IDS in DI/CSV related deviations and CAPAs.
• Provide support in the event of internal, external, and regulatory audits.
• Partner cross-functionally with site DI SMEsto ensure a common, systematic approach to meeting existing and new DI/CSV expectations. This includes, but is not limited to, audit trail management, workstation security, and connecting stand-alone equipment.
• Solves problems while exhibiting judgment.
• Ensures Lilly information assets are protected from malicious content and access to information is restricted to authorized personnel only
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

• Experience working in a regulated industry (i.e., GMP) and strong understanding of quality processes in IT applying to manufacturing and distribution.
• Proficiency with CSV and demonstrated ability to right-size validation based upon risk.
• Ensure compliance and inspection readiness for DI/CS across the IDS computer systems used at the Concord site.
• Bachelor's Degree in Business Administration with Major in Information Systems, Computer Science or Programming; or BS in IT, Chemistry, Pharmacy, Science, Engineering or equivalent.
• Ability to communicate effectively in written and verbal form (in English), with proven success at delivering key messages to both management and peers across multiple business functions.

• Working knowledge of IT applications and/or hardware utilized within Parenteral operations.
• Knowledgeable of Parenteral Products manufacturing and packaging.
• Working knowledge of IT Life Cycle management, IT Business Process Model, S95 model, LSEF, and other IT processes

• 8-hour days, possible after-hour support
• Occasional travel may be required.