Senior Associate
2 days ago
We are seeking a highly skilled Senior Associate - Computer Systems Validation to join our team at Eli Lilly. As a key member of our Quality Assurance department, you will be responsible for ensuring the integrity of our computer systems and data.
Responsibilities- Deliver on CSV processes and Data Integrity Sustainability
- Establish and maintain CSQ support and DI sustainability processes
- Drive appropriate consistency in CSQ and DI controls
- Deliver Projects and Programs
- Understand and maximize business value of Data integrity controls in computer systems
- Provide consulting and right-sizing of DI activities for GMP computer systems based on risk and value
- Provide linkages to partner organizations with CSV and DI including Automation, Site C&Q, BQA, and other CSQA persons
- Grow Capabilities and Knowledge
- Mentor others in DI and CSV-related roles
- Grow capabilities of those performing DI CSV activities
- Maintain Inspection Readiness
- Provide consulting and interpretation on Corporate Computer Systems/Data Integrity standards and practices as implemented at the LP1 facility
- Provide cross-functional technical leadership in the event of serious quality-related issues with computer systems or data integrity
- Monitor current state of inspection-readiness
- Escalate issues
- Bachelor's degree in Computer Science, Engineering, Mathematics, Life Sciences, or a technology-related field
- 1+ year of experience in Automation/QC Labs/IT, Quality, or computer system validation in the pharmaceutical industry
- Direct experience with Computer Systems Validation (GAMP5) and data integrity basic principles (ALCOA+)
- Previous experience in GMP or GLP environments
- Demonstrated strong oral and written communication skills
- Strong interpersonal interaction skills
- Proven ability to influence quality peers, IT SMEs, and upper management
- Previous experience in Business Quality Assurance and Automation
- Understanding of process development and/or improvement (e.g. Six Sigma)
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs.
We are an EEO/Affirmative Action Employer and do not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles
We have several ERGs, including the African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, and Working and Living with Disabilities.
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