IBU - Quality Analyst-1

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

Contact Details: [email protected]

Lilly International Business Unit Solution Services (IBU SS) is accountable for “Delivery” and “Operational" Excellence of the application portfolio and services consumed by the commercial affiliates within the geography. Working across 120+ countries, IBU SS delivers multi-channel, digital, web, mobile, productivity and analytics services and solutions; supports the operations of the multi-channel content (marketing tactics production) and provides service management (support) to those services through a diverse and high-performing team located across 19 countries.

The IT Quality Analyst position reports to IT Quality Lead and works with application/systems owners, custodians and relevant business partners to implement IT Quality Process and Standards defined by Lilly. This includes development of IT Quality Documents and maintenance of the IT Asset inventory using Lilly specified tools and templates.
KEY Responsibilities

IT Policies / Procedures / Guidelines

• Works with customers and peers in the application of policies, procedures, and regulations with a focus on addressing concerns that could alter the course of process guidance or execution
• Serves as a subject-matter expert (SME) for system-related documentation creation
• 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 geographies.
• Experience dealing with business partners in multiple affiliates
• Experience with IT Quality management processes, tools and techniques
• Demonstrated interpersonal skills, collaboration and teamwork
• Strong communication written and verbal
• Self-motivated to priorities and complete multiple tasks without direct supervision
• Good understanding of IT Quality Processes, Documentation e.g., System Retirement, Periodic Reviews, System Validation etc.
• Experience with systems development life cycle (SDLC)

Essential Skills:

• Effective analytical, problem solving and investigative skills
• Ability to collaborate with technical and non-technical colleagues
• Ability to resolve issues across geographical and cultural boundaries
• Evidence of creativity, pro activity and influencing skills
• English, fluent - oral & written communication. An additional language is an advantage

Desirable Skills:

• Experience in Pharma Industry or regulated industry
• Prior Experience in IT system development, QA or technical writing
• ITIL experience

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does 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 status.

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