Senior Associate IS Business Systems Analyst

Overview

Support GRC processes for IS and GxP by monitoring GxP records, supporting IS CDOCs document management, assessing compliance risks, and contributing to regulatory compliance reporting.

What you'll do

• Identify and assess potential compliance risks through GxP and IS CDOCs monitoring, and escalate concerns to the process owner.
• Monitor GxP deviation, CAPA, and CAPA-EV records for status, due dates, completeness, and required follow-up.
• Follow up with record owners on routine actions and escalate overdue items, gaps, or potential compliance concerns to the process owner.
• Respond to routine GxP process questions and guide users on record requirements and established procedures.
• Support GxP office hours, process guidance sessions, and stakeholder meetings; help identify recurring questions or process issues.
• Review IS CDOCs reports and workflows to track open actions, aging documents, upcoming periodic reviews, and approval or routing issues.
• Follow up with document owners and stakeholders to support timely reviews, revisions, and approvals.
• Provide routine process guidance to document owners, authors, reviewers, and approvers on established CDOCs requirements.
• Support document traceability, version control, office hours, and stakeholder meetings; escalate workflow or compliance issues as needed.
• Collaborate with IS, cybersecurity, quality, and business stakeholders to resolve issues and support process needs.
• Troubleshoot issues, support end users, and contribute to IT projects and process improvements.

What you'll need

• Bachelor's degree and 5–9 years of relevant experience in computer science, information technology, cybersecurity, risk management, or a related field.
• Solid understanding of IT infrastructure, systems, and standard processes.
• Excellent problem-solving, analytical, and communication skills.
• Hands-on experience with electronic document management systems (e.g., Veeva/CDOCs) and quality management systems (e.g., TrackWise) in regulated environments.
• Strong verbal and written communication skills.
• Ability to work effectively with global, virtual teams.
• Ability to manage multiple priorities successfully.
• Team-oriented, with a focus on achieving team goals.
• Strong presentation and public speaking skills.

Nice to have

• Ability to understand and interpret policies, standards, and regulatory requirements (e.g., CDOCs, GxP, FDA 21 CFR Part 11) with guidance.
• Knowledge of Computer System Validation (CSV).
• Awareness of reporting, automation, or AI-enabled approaches to improve IS process efficiency and documentation quality.
• Experience with ChatGPT or Copilot.
• Experience with SharePoint.

Details

• Location: India - Hyderabad.
• Employment type: Full time, 40 scheduled weekly hours.
• Work shift: Flexi Shift (India).