Location: Pan India

Experience: 5 - 8 Years

Employment Type: Contract

Work Mode: Hybrid

Position Title - TQ&C; Consultant

Position Summary

TQ&C; Consultant is responsible for supporting GxP-regulated projects by developing, reviewing, assessing, and providing validation expertise for computerized systems throughout the system development lifecycle (SDLC). The role ensures compliance with applicable regulatory requirements, quality standards, and internal validation procedures while collaborating with cross-functional business, quality, and technology teams.

The consultant contributes to validation strategy, risk assessments, testing activities, traceability, change management, and compliance documentation to support the implementation and maintenance of validated systems.

Key Responsibilities

Computer Systems Validation
- Develop and maintain validation documentation in accordance with GxP, SDLC, and other regulatory requirements.
- Prepare Compliance Plans and Compliance Summary Reports for computerized system implementations and enhancements.




- Review and provide feedback on validation deliverables produced by project teams.
- Ensure validation activities are executed in alignment with company SOPs and quality management system requirements.
- Support validation efforts throughout project initiation, design, testing, deployment, and closure phases.

Risk and Compliance Assessment
- Perform and review GxP Compliance Assessments.
- Review and assess CSV Risk Assessments to determine the appropriate validation strategy.
- Evaluate system changes for regulatory and business impact.
- Ensure validation deliverables comply with FDA, GxP, 21 CFR Part 11, and applicable industry regulations.

Requirements and Design Reviews
- Review User Requirements and User Stories.
- Verify that requirements are explicit, testable, traceable, and aligned with intended business use, following SMART definitions.
- Collaborate with business and technical stakeholders to resolve valida

📌 Computer System Validation Consultant (India)
🏢 Orcapod Consulting Services
📍 India