Eli Lilly Looking for ISQ – Information Systems Quality Rep at Bengaluru, Karnataka Full Time

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 35,000 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.

The Computer Systems Quality Assurance role is responsible for ensuring the Functional Area(s), Project(s) or System(s) to which they are assigned are in compliance with corporate Computer System Validation (CSV) standards. This includes providing consulting and interpretation of Corporate Computer Systems Standards and Practices (CCS-LQS/LQPs), providing oversight for CSV execution (including approving CSV documents per corporate standards/practices), maintaining awareness of corporate and external standards as they relate to CSV, and assurance of inspection readiness within supported areas.

Key Objectives/Deliverables:
Maintain Inspectional Readiness

Ensure supported systems are validated in compliance with CCS-LQS/LQPs

Ensure all quality actions and commitments for supported areas are appropriately tracked in Quality/CAPA plans

Participate in self inspections, audits, and supplier assessment activities to ensure the state of computer system validation is clearly and accurately understood

Ensure all Inspection Readiness materials (e.g. Tier 1-4) are current and appropriate

Provide periodic updates to key stakeholders

Escalate issues appropriately

Deliver Projects, Programs, and Support

Provide consulting and interpretation on CCS-LQS/LQPs as related to the supported computer system

Provide training to customer areas on CSV-related topics as needed

Partner with Business, Business Quality, and IT customer areas to deliver business value

Understand customer, company, and Quality priorities

Review/approve documents per CSV expectations within agreed service levels, or clearly communicate when activities will be completed

Engage customers and QA management in appropriate discussions of risk management

Ensure suppliers of computer systems or services meet quality expectations

Escalate computer system quality issues to the appropriate persons

Strive for and promote consistency within the CSQA Organization

Streamline and Continuously Improve

Eliminate non-value added activities in order to focus on activities which continuously improve assurance of quality. This may include engagement in process improvement projects.

Identify opportunity for streamlining and simplification and assist in developing improved solutions

Understand external trends and potential ramifications for the supported IT area(s)

Grow Capabilities and Knowledge

Share lessons learned and best practices with others

Act as an engaged team member

Minimum Requirements:
Bachelor (4 yr College) degree in a technology-related field such as Computer Science; or equivalent experience (i.e., 5+ years experience in Automation/IT or computer system validation)

Demonstrated strong oral and written communication, interpersonal interaction skills, and ability to influence and collaborate

Proficiency with IT systems development life cycle

Proficiency with Computer Systems Validation and demonstrated ability to right-size validation based upon risk

Ability to focus across multiple processes (end-to-end viewpoint)

Prior IT system development experience or QA experience

Additional Preferences:
Understanding of process development and/or improvement (e.g. Six Sigma)

Experience conducting risk assessments, self-inspections, audits and/or supplier assessments

Knowledge of multiple Lilly business areas

Broad IT technical competency

Ability to relate system use to potential impact to products and patients

Knowledge of IT Best Practices (e.g., COBIT, LSEF, ITIL, GAMP)

Practical application of IT-control related certifications (e.g., CISA, ISO, ITIL, CSQE (ASQ, QAI))

Other Information:
QA Representative must complete CSQA Qualification Program

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. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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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