- 15+ years
Lead and execute risk-based IT audits across Sun Pharma's GxP systems, infrastructure, applications, and technology processes, ensuring compliance with regulatory and data integrity requirements.
Responsibilities
- Plan and execute risk-based IT audits across Sun Pharma's GxP systems, infrastructure, applications, and technology processes.
- Assess compliance with Data Integrity requirements, Computer System Validation (CSV) principles, internal policies, and applicable regulatory expectations including USFDA, MHRA, EMA, and WHO guidelines.
- Evaluate IT General Controls (ITGCs) including user access management, segregation of duties, password controls, change management, backup and recovery, business continuity and system documentation life cycle controls.
- Review enterprise systems, laboratory systems, manufacturing systems, quality systems, and cloud-based applications for compliance, security, and data integrity risks.
- Conduct thorough reviews of audit trails, system logs, electronic records, and user activities to identify process deviations.
Requirements
- Master of Science / B Pharmacy or equivalent