Senior Consultant - Digital Validation & IT Compliance
Eli Lilly and Company (company site, opens in a new tab)8+ yrsHyderabadOn-siteDirect career pageEst. 18–30 LPA
Posted 17h ago
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Job description
Structured overview of role & requirements
About This Role
- Drive Computer System Validation (CSV) and Computer Software Assurance (CSA) activities ensuring compliance and quality across Lilly computer systems.
- Lead IT system validation lifecycle including planning, documentation review, and reporting, ensuring adherence to regulatory requirements and company standards.
- Innovate and automate validation processes by leveraging AI, digital tools, and automation technologies to improve efficiency while maintaining compliance.
Minimum Requirements
- Bachelor’s degree in Computer Science, Information Technology, or related field.
- 8-10+ years experience in CSV within pharmaceuticals or life sciences industry.
- Extensive knowledge of GxP, regulatory requirements, and IT system validation processes such as FDA 21 CFR Part 11, EU Annex 11, GAMP 5.
- Work Experience Required: 8-10+ years in relevant CSV and IT compliance roles.
Ideal Candidate Profile
- Experienced in leading CSV projects covering full system lifecycle including implementation, upgrades, and retirement.
- Proficient in applying risk-based validation approaches aligning with CSA principles to balance compliance and efficiency.
- Strong collaborator able to work with cross-functional teams and communicate regulatory requirements effectively.