Job Description
Experienced IT Applications Lead with strong expertise in business–IT liaison, stakeholder management, vendor coordination, and end‑to‑end system validation in GxP-regulated environments. Skilled in understanding business requirements, proposing optimal system solutions, and ensuring compliance with global quality and regulatory standards throughout the application lifecycle.
Key Responsibilities
1. Business–IT Coordination
- Act as a bridge between business users, QA, and external IT vendors.
- Gather, analyse, and translate business requirements into functional specifications.
- Suggest feasible technical solutions aligned with business needs and compliance standards.
2. Project Management
- Lead end‑to‑end project lifecycle including planning, execution, monitoring, and closure.
- Manage project timelines, deliverables, risks, and resource coordination.
- Conduct periodic project review meetings and ensure timely reporting to stakeholders.
3. Application Support & Lifecycle Management
- Provide Level‑2/Level‑3 support for critical IT applications.
- Ensure application stability, performance, and availability.
- Oversee periodic review of systems and ensure documentation accuracy.
4. GxP Compliance & Validation
- Plan and execute end‑to‑end validation of computerized systems (CSV).
- Prepare and review validation documents (URS, FRS, IQ/OQ/PQ, Traceability Matrix, Reports).
- Ensure systems meet 21 CFR Part 11, GAMP 5, and other regulatory guidelines.
5. Quality Management System (QMS)
Prepare QMS records such as:
1. Deviations
2. Change Controls
3. CAPA
4. Incidents & Investigations
Ensure adherence to internal quality procedures and regulatory requirements.
6. Vendor & Stakeholder Management
- Coordinate with external vendors for system development, enhancements, and issue resolution.
- Manage stakeholder expectations and ensure smooth communication across teams.
7. System Implementation & Upgrades
- Support system design, implementation, configuration, and migrations.
- Manage upgrades, patching, and release cycles.
- Ensure alignment with organizational IT and data integrity policies.
8. Skills & Competencies
- Strong understanding of SDLC and validation lifecycle in GxP systems.
- Hands-on experience with CSV, 21 CFR Part 11, GAMP 5 guidelines.
- Expertise in IT application management and support.
- Experience in reviewing technical/validation documentation.
- Excellent communication, stakeholder management, and vendor handling skills.
- Strong analytical and problem‑solving abilities.
- Ability to manage multiple projects in parallel.
Pay: ₹30,000.00 - ₹33,000.00 per month
Benefits:
Application Question(s):
- Current CTC
- Expected CTC
- Notice Period
- Okay to work on Third Party Payroll?
- How many years of experience in regulated industries (Pharma/Life Sciences preferred)?
- Bachelor’s or Master’s degree in IT, Computer Science?
Location:
- Gurugram, Haryana (Required)
Work Location: In person
