Senior CSV Validation Consultant

EY; Hyderabad; Hybrid; INR 1,800,000 - 2,600,000; Full time

Job summary

EY is seeking an experienced Senior Consultant (Validation/Tester Veeva QMS) to lead validation, testing, and compliance across Veeva QMS modules for global pharmaceutical clients. The role emphasizes FDA/EMA/MHRA standards and risk-based, agile integration to support business transformation.

The candidate should have 5+ years in CSV within life sciences, strong regulatory knowledge (GAMP 5, 21 CFR Part 11, Annex 11), and excellent stakeholder management. Consulting experience is preferred.

Qualifications

• 5+ years in CSV within pharma, life sciences, or consulting.
• Familiar with GAMP 5, 21 CFR Part 11, Annex 11.
• Excellent communication and stakeholder management.
• Consulting or client-facing experience preferred.
• Strong documentation and problem-solving skills.

Responsibilities

• Lead validation, testing and compliance across Veeva QMS.
• Define CSV/CSA strategies and risk-based approaches.
• Integrate validation into Agile delivery.
• Oversee AI/ML governance and validation.
• Prepare URS, FRS, IQ/OQ/PQ, Traceability Matrix, and Summary Reports.
• Coach teams on templates and quality standards.
• Ensure data integrity and inspection readiness.

Skills

CSV/CSA docs

Veeva QMS

GxP systems

Agile

Test scripts

Stakeholder mgmt

Project management

Education

Bachelors or Masters in Biotechnology/Engineering

Tools

Jira

Confluence

qTest

HP ALM

Xray

Valgenesis

Job description

Job Summary

We are seeking an experienced Senior Consultant (Validation/Tester Veeva QMS) to lead validation, testing activities and compliance across various Veeva QMS modules, regulated and business critical computerized systems for global pharmaceutical clients. The ideal candidate will ensure compliance with global regulatory standards (FDA, EMA, MHRA) and drive strategic initiatives for business process transformation and operational excellence.

Your Key Responsibilities

• Lead validation, testing and compliance activities across Veeva QMS modules and other GxP and non-GxP systems, aligning with global regulatory requirements and client objectives.
• Define and drive CSV/CSA strategies, enabling transition from traditional validation to risk-based assurance models.
• Integrate validation and testing into Agile delivery models, ensuring compliance is embedded within iterative development cycles.
• Oversee AI/ML governance and validation, including model risk management, data integrity, explainability, and compliance with emerging regulatory expectations.
• Conduct impact assessments, gap assessments, and remediation for legacy and transforming systems. Author and review deliverables including URS, FRS, Risk Assessments, Validation Plans, IQ/OQ/PQ protocols, Traceability Matrix, and Summary Reports.
• Develop and execute risk-based testing strategies, test scripts for Functional Testing & User Acceptance Testing of Veeva QMS and other GxP systems.
• Serve as a trusted advisor to clients across critical Veeva QMS quality processes, including change management, CAPA, deviations, investigations, and associated documentation, helping deliver compliant solutions and high-quality deliverables.
• Ensure data integrity and inspection readiness across systems.
• Coach and guide project teams on proper usage of templates, documentation expectations, and quality standards.

Qualifications

• Bachelors or Masters degree in Biotechnology, Engineering, or related field.
• 5+ years in CSV within the pharmaceutical, life sciences or consulting organizations.
• Strong understanding of regulatory requirements including, GAMP 5, 21 CFR Part 11, Annex 11.
• Consulting or clientfacing experience preferred.
• Excellent communication, documentation, and stakeholder management skills.

Must-Have Skills & Attributes

• Strong expertise in CSV/CSA documentation: Gap Analysis, URS, FRS, IQ/OQ/PQ, Risk Assessments, Traceability Matrix, Validation Plans.
• Proven experience in validation, testing and compliance activities across Veeva QMS modules and other GxP and non-GxP systems.
• Strong experience in development and execution of test scripts for Functional Testing, User Acceptance Testing of GxP systems.
• Experience with tools like Jira, Confluence and test management tools like qTest, HP ALM, Xray, Valgenesis, etc.
• Experience working in Agile delivery models.
• Strong stakeholder management and client facing skills, with ability to collaborate across business, IT and quality teams
• Strong project management, problem solving and communication skills

Good-to-Have Skills & Attributes

• Exposure to business development activities and client engagement strategies.
• Automation testing experience with tools like Tricentis Tosca, Selenium, Leapwork, etc. is an added advantage.
• Experience with other QMS platforms such as TrackWise, MasterControl and ETQ Reliance.
• Understanding of AI/ML lifecycle, governance and validation skills.
• Ability to align technology with business transformation goals.
• High attention to detail and analytical thinking.
• Familiarity with emerging regulatory trends, such as CSA or digital validation approaches.
• Adaptability to changing regulatory and business environments.

Preferred Certifications

• Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA)
• Information Security or Risk Management certifications.
• Any Veeva Quality certification.

What we look for

• A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
• An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
• Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries.