Senior Associate IS Business Systems Analyst
Amgen (company site, opens in a new tab)5–9 yrsHyderabadOn-siteDirect career pageEst. 12–20 LPA
Posted 20h ago
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Job description
Structured overview of role & requirements
About This Role
- Support GRC processes for Information Systems and GxP compliance including monitoring records, assessing compliance risks, and escalating issues.
- Manage IS electronic document control (CDOCs) by tracking document workflows, approvals, and facilitating timely reviews.
- Collaborate with IS, cybersecurity, quality, and business stakeholders to troubleshoot, communicate, and improve compliance-related processes.
Minimum Requirements
- Bachelor’s degree in computer science, IT, cybersecurity, risk management, or related field.
- 5–9 years of relevant experience in IT, cybersecurity, risk management, or related fields.
- Hands-on experience with electronic document management systems (e.g., Veeva/CDOCs) and quality management systems (e.g., TrackWise) in regulated environments.
- Work location and shift: Full-time, 40 hours/week, flexible shift in India.
Ideal Candidate Profile
- Experienced with GxP and regulatory compliance frameworks including understanding of FDA 21 CFR Part 11 and Computer System Validation under guidance.
- Familiarity with IT infrastructure, risk identification, remediation tracking, and process improvements in regulated environments.
- Comfortable working with global and virtual teams to manage complex compliance operations and documentation workflows.