IBU - Quality Analyst-1
1 month ago
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:
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) requirementsSystems 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 requestsSystems 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 requirementsSystem 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 policiesSystem Periodic Reviews / Access Roster Reviews
Supports development of yearly Periodic Reviews / Access Roster reviews plan Facilitates system periodic reviews, access roster reviewsPersonnel 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 deliverablesIT Audit / Inspection Support
Assists affiliate IT in audit readiness activities Assists affiliate IT in IT Inspections readiness activitiesof 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 NowQuality 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 expectationsRequired 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 advantageDesirable Skills:
Experience in Pharma Industry or regulated industry Prior Experience in IT system development, QA or technical writing ITIL experienceLilly 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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