TQ&C Consultant

Position Overview

We are seeking a TQ&C Consultant to support GxP-regulated projects by offering validation expertise for computerized systems during their entire system development lifecycle (SDLC). This position ensures adherence to regulatory requirements, quality standards, and internal procedures, while working closely with business, quality, and technology teams.

Key Responsibilities

• Create and update validation documentation based on GxP, SDLC, and related regulatory guidelines.
• Develop Compliance Plans and Summary Reports for new and enhanced computerized systems.
• Evaluate validation outputs from project teams and provide constructive feedback.
• Coordinate validation activities to align with company SOPs and quality systems throughout project phases.
• Conduct and review GxP compliance and risk assessments to determine validation strategies.
• Analyze system changes for regulatory impact and ensure validation complies with FDA, GxP, and 21 CFR Part 11 standards.
• Review User Requirements and User Stories to ensure clarity, testability, traceability, and business objective alignment.
• Assist with resolving validation and compliance challenges alongside stakeholders.
• Oversee User Acceptance Testing (UAT) and support System Integration Testing (SIT) with thorough test reviews and defect management.
• Maintain Traceability Matrices linking requirements, risks, tests, and controls ensuring audit-readiness of documentation.
• Review change control records for compliance and validate system modifications.
• Collaborate with Quality Assurance, Business Owners, IT, and Vendors to provide CSV guidance throughout project lifecycles.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Computer Science, Information Systems or related discipline.
• 5-8 years of experience in Computer System Validation (CSV) within pharmaceutical, medical device, or other regulated sectors.
• Comprehensive understanding of GxP regulations, FDA 21 CFR Part 11, risk-based validation methods, SDLC methodologies, change control, and testing.
• Experience reviewing and approving validation deliverables and test documentation.
• Knowledge of Quality Management Systems and regulatory compliance.

Preferred Skills

• Experience with Agile and Scrum frameworks.
• Familiarity with validations in ERP, MES, LIMS, Quality, Regulatory, R&D, and Manufacturing applications.
• Expertise in creating lifecycle validation documents including Validation Plans, Risk Assessments, UAT/SIT documentation, and Traceability Matrices.
• Strong analytical thinking, problem-solving, and communication capabilities.

Additional Details

Location: Pan India (Hybrid Work Mode)

Employment Type: Contract

Experience Required: 5-8 years

Openings: Not specified

Joining: Immediate joining preferred

Eligibility: Any graduate

Work Hours: Not specified