Global Computer Systems Quality Assurance Rep

3 months ago

Bengaluru Karnataka, India Lilly 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 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.

Organization Overview:
The Computer Systems Quality Assurance Representative 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, 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.

**Responsibilities**:

- Maintain Inspectional Readiness_
- Ensure supported systems are validated in compliance with applicable policies and procedures
- 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 are current and appropriate
- Provide periodic updates to key stakeholders
- Escalate issues appropriately
- Deliver Projects, Programs, and Support_
- Provide consulting and interpretation on standards and procedures 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 Six Sigma projects and other process improvement activities.
- 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

Basic Requirements:

- Bachelor (4 yr. College) degree in a technology-related field such as Computer Science.
- 3+ 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 corporate Computer Systems Validation practices and demonstrated ability to right-size validation based upon risk
- Ability to focus across multiple processes (end-to-end viewpoint)

Additional Skills/Preferences:

- Understanding of process development and/or improvement (e.g. Six Sigma)
- Knowledge of multiple 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., LSEF, ITIL)

Additional Information:
QA Representative must successfully complete the Lilly CSQA Qualification Program

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.

WeAreLilly

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.

WeAreLilly

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