The Senior Principal Consultant - Validation leads enterprise‑level validation strategy by shaping frameworks,
harmonizing standards across portfolios, and ensuring global regulatory compliance while driving high‑risk
programs, organizational capability building, and long‑term CSV transformation with executive stakeholders.
ROLE AND RESPONSIBILITIES
• Assisting the authoring and execution of test scripts (OQ, PQ, UAT etc.)
• Independently developing test scripts
• Ability to assist in the development of validations deliverables
• Assisting in the development of migration deliverables (ie, queries for migration testing)
• Independently develop validation deliverables.
• Peer review test scripts against the requirements
• Assist in providing work effort estimates for testing phase
• Lead end-to-end the validation workstream for a internal/client project (planning, execution,
monitoring, closure)
• Assist in pre-sales activities (e.g., presentations, preparing proposals for clients
• Provide Subject Matter Expertise on current GxP regulations and standards (e.g., 21 CFR Part
11,
EU Annex 11, GAMP)
• Co-leading pre-sales activities
• Lead audit readiness for internal/external audits
• Direct, supervise and mentor colleagues
Additional Responsibilities
• Apply CSV documentation standards
• Participate in test planning
• Independently develop validation deliverables
• Independently develop data migration validation deliverables
• Train Prudentia employees on CSV policies and deliverables
• Conduct validation knowledge transfer sessions for clients
• Direct and supervise L0 and L1 colleagues
• Manage project issues/risks and report to management
• Consult clients on validation approach
• Assist in CSV practice development such as developing templates, guides, and process improvement
(SOPs)
• Assist in audit readiness for internal/external audits
• Manage validation tracks across multiple projects
• Lead CSV practice development and process improvements
• Collaborate w
📌 Senior Consultant (Noida)
🏢 Ergomed
📍 Noida