IT Projects Implementation team member

Job Description:

Responsibilities

• Lead assigned rollout tasks of global quality applications.
• Define project scope, timelines, and resource allocation in collaboration with stakeholders.
• Conduct detailed business process analysis across departments like R&D, QA, Regulatory Affairs, and Manufacturing.
• Translate complex workflows into validated technical requirements.
• Architect scalable, compliant solutions aligned with GxP, FDA 21 CFR Part 11, and data integrity principles
• Oversee configuration and customization of applications to meet regulatory and operational needs.
• Perform testing of new features/ bug fixes.
• Perform Computer System Validation (CSV) efforts form IT perspective.
• Ensure systems meet audit-readiness standards and support inspection readiness
• Coordinate with CFTs and vendors
• Facilitate workshops, demos, and UAT sessions with cross-functional teams
• Investigate and resolve complex application issues and coordinate with vendors for L3/L4 support.
• Analyze root causes and implement long-term fixes
• Manage application upgrades, patches and enhancements through formal QMS processes.
• Monitor system performance and proactively optimize configurations.
• Support internal and external audits by providing system documentation, logs, and compliance evidence

Qualification & Experience

•  BE/B.Tech IT or Computer Engineering.
•  BCA/MCA
•  BSc/MSc IT
• Experience: 6 to 8 years (Experience with APQR rollout shall be preferred)