(15h Left) GxP Systems Specialist

Accountable for implementation / delivery of Veeva applications to meet Ocugen business needs with a focus on regulated functions :

• Serve as a subject matter expert in business and system administration with extensive hands-on experience configuring Veeva Vault platforms, including Quality, QMS, Training, Clinical, and RIM applications.
• Evaluate Veeva general releases, conduct assessments / proof of concepts (POCs), and develop business cases for implementing new enhancements or configurations to align with enterprise needs.
• Lead and oversee change controls, manage system deviations, and drive continuous improvement initiatives. Ensure all activities are performed in accordance with defined GxP processes and are appropriately documented to maintain compliance.
• Ensure critical system operations activities—such as access management, periodic reviews, configuration updates, and data integrity monitoring—are performed in compliance with established GxP procedures and operational standards.
• Support change management initiatives to ensure effective planning, communication, and adoption of new systems and processes.
• Liaise with computer system vendors, Quality, and business stakeholders to coordinate implementation activities, applying vendor management best practices.
• Help define project scope and deliverables to support business goals in collaboration with senior management stakeholders.
• Identify opportunities for innovation and process optimization based on evolving client and regulatory requirements
• Work with the business to develop and document system and user requirements aligned with GxP principles and 21 CFR Part 11 compliance. Revision Date : 1 / 2018 Job Description Template JOB DESCRIPTION
• Define and oversee documentation of configuration and design specifications.
• Contribute to the authoring and execution of implementation plans, qualification tests, and computerized system validation (CSV) documentation.
• Develop and maintain CSV standards, procedures, and work instructions to ensure consistent execution and regulatory compliance.
• Provide support for internal audits and regulatory inspections by ensuring system readiness, documentation accuracy, and timely response to findings or queries.
• Provide support during U.S. business hours, as required, to ensure incident / issue system resolution across global teams.

Management Of GxP Systems Lifecycle :

Analyze user enhancement requests to deliver solutions focused on establishing and improving business processes that improve efficiency, address process gaps, and enable automation and growth of the organization.