We are looking for Validation Engineer
Location : Gurgaon
Experience : 4+ Years
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.
Kindly share your updated resume