Ibu - Quality Analyst-1
3 weeks ago
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.
Job Title:
IBU Solution Services - IT Quality Analyst (Quality Analyst II)
Contact Name: Shubhra Verma
KEY Responsibilities
IT Policies / Procedures / Guidelines
- Understands Lilly System Engineering Framework (LSEF)
- Actively contributes to continuous improvement for documentation and validation processes for functional area
- Develops deep level of understanding of CSV policies and procedures, SOPs and business processes for assigned customer area
- Participates in translation of policies and procedures into localized, functional area SOPs
- Adheres to corporate and IT computer systems validation policies and procedures.
Computer System Validation
- Ensures deliverables meet regulatory, IT, and business expectations
- Ensures that system deliverable fulfills the requirement of its intended use
- Ensures and reinforces the Computer Systems Quality (CSQ) policies and procedures
- Ensures completion of all appropriate Computer Systems Validation (CSV) requirements
Systems Change Management
- Ensures IT system change requests are executed in compliance with Local/Regional change control procedures
- Ensures the accuracy, completeness, and quality of all change requests
Systems Custodianship
- Ensures that systems are developed, installed, maintained, supported and validated according to applicable (e.g., may not be Lilly) corporate and local policies and procedures.
- In conjunction with the System Owner must ensure that data is retained pursuant to the records retention schedule and any applicable legal hold.
- During an audit or regulatory inspection, the System Custodian has the responsibility for representing the specific validation documentation for which that person is a custodian.
- Supports system owners, project team members, and other resources by participating in up-front planning activities, risk assessment activities, providing feedback on validation decisions and deliverables
- Evaluates and maintains relationship with suppliers (both those providing the software & any services)
- Ensures that appropriate system support procedures are established and followed
- Maintains relationship with key business roles (e.g., System Owner, power users)
- Reviews & approves system validation documentation
- Ensures that security controls are put in place to adequately protect the data
- Assures that privileged accounts for the system and any supporting tools (e.g., Quality Center, TFS) are periodically reviewed
- Determines extent of Disaster Recovery required
- Oversees Unit, Integration, & System Testing to ensure system meets requirements
System Retirements
- Schedules and maintains IT System Retirement Plan
- Drives retirement of IT systems in partnership with the business
- Ensures IT Assets are retired and documented as per Lilly policies
System Periodic Reviews / Access Roster Reviews
- Supports development of yearly Periodic Reviews / Access Roster reviews plan
- Facilitates system periodic reviews, access roster reviews
Personnel Qualification (IT Trainings)
- Supports the management of IT Training Grid and Curricula
- Supports Personnel Qualification review as per global guideline
- Supports assignment of IT Trainings in tools provided
- Supports System Owner and End User training related to CSQ Policies and Procedures and functional area validation activities
- Ensures system owners, system custodians, and project teams are knowledgeable of their responsibilities in defining, producing, approving deliverables
IT Audit / Inspection Support
- Assists affiliate IT in audit readiness activities
- Assists affiliate IT in IT Inspections readiness activities
of IT Asset Inventory Management
- Ensures IT Inventory is managed as per corporate guideline
- Ensures timely data modifications in IT Inventory tool/database
- Supports IT Inventory periodic audits
- Experience working with Service Now
Quality Support during Project Delivery
- Works with project team members to interpret or explain the guidelines regarding system validation
- Monitors project timetable and progress for quality tasks
- Manages project issues related to quality/validation
- Reviews quality related deliverables for accuracy and appropriate thoroughness
- Ensures quality deliverables meet regulatory, IT, and business expectations
Required Experience:
- 5+ Years of Experience
- Working with multiple internal IT organizations or external suppliers, virtually and across different
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