Senior Consultant – Computer System Validation (CSV) | SAP | Deloitte India | Bengaluru

Job Description

Summary

Join Deloitte India as a Senior Consultant – Computer System Validation (CSV) in Bengaluru and contribute to transforming how life sciences and healthcare organizations ensure compliance, quality, and operational excellence. This role is ideal for professionals with strong experience in GxP systems validation, SAP systems, and regulated environments (21 CFR Part 11, EU Annex 11, GMP).

As a Computer System Validation (CSV) Consultant, you’ll collaborate with cross-functional teams to validate enterprise systems, ensure data integrity, and streamline validation processes across global healthcare and life sciences operations. If you’re passionate about quality, compliance, and digital transformation in regulated industries, this opportunity is for you.

Job Details at a Glance

About the Role

As a Senior Consultant – Computer System Validation (CSV) at Deloitte, you will lead and execute validation strategies for enterprise-level systems supporting the life sciences and healthcare (LSHC) industry. You’ll ensure compliance with global regulatory standards, design validation frameworks, and support audits and inspections to maintain a validated system environment.

Key Responsibilities

Validation & Compliance

• Develop and execute end-to-end validation strategies for IT systems and SAP environments.
• Ensure adherence to GxP, GMP, 21 CFR Part 11, 21 CFR Part 820, and EU Annex 11 regulatory standards.
• Define validation deliverables, including GxP Assessments, Validation Plans, URS, FRS, IQ/OQ/PQ, and Validation Summary Reports.
• Maintain validated system states through Periodic Reviews, CAPA handling, and deviation management.

System & Process Oversight

• Perform validation and quality assurance for ERP, MRP, QMS, and LIMS systems.
• Oversee cloud validation, data migration, and infrastructure qualification for GxP-relevant systems.
• Support supplier assessments and manage risk assessments (IT, Data Privacy, Requirement Risks).
• Track deviations, conduct root cause analysis (RCA) using “5 Whys” or similar methods, and implement CAPAs.

Testing & Quality Management

• Define test strategy, test plans, and validation scripts for SDLC phases.
• Conduct validation testing, record outcomes, and ensure traceability across project documentation.
• Support internal audits and external inspections to ensure compliance with industry standards.

Leadership & Collaboration

• Collaborate with business, IT, and QA teams to drive effective validation processes.
• Train and mentor team members on CSV processes and regulatory compliance.
• Facilitate workshops, manage stakeholders, and lead cross-functional validation projects.

Required Skills

• Minimum 5 years of experience in Computer System Validation (CSV) and Quality Assurance within regulated life sciences or healthcare industries.
• Deep understanding of GMP, GxP, 21 CFR Part 11, EU Annex 11, and related compliance standards.
• Experience in enterprise-level system validation (ERP, MRP, QMS, LIMS).
• Hands-on expertise in Data Migration, Cloud Validation, Supplier Assessment, and Infrastructure Qualification.
• Proficiency in creating and reviewing validation deliverables (URS, FRS, IQ/OQ/PQ, Test Plans).
• Familiarity with Change Request Management and Risk Assessment processes.

Personal Attributes

• Excellent written and verbal communication skills in English.
• Strong interpersonal and stakeholder management skills.
• Highly organized, flexible, and capable of managing multiple priorities.
• Ability to perform effectively under pressure and handle ambiguity.
• Collaborative mindset with leadership and mentoring capabilities.
• Self-motivated with a focus on quality, accuracy, and process improvement.

Why Join Deloitte

At Deloitte India, you’ll work on high-impact SAP and CSV transformation projects for leading life sciences organizations. You’ll benefit from:

• Exposure to global regulatory environments and enterprise validation programs.
• Opportunities to lead strategic quality and compliance initiatives.
• A culture of learning, innovation, and career growth.
• A collaborative work environment that values integrity, excellence, and diversity.

Career Growth

This role offers a pathway to senior leadership opportunities in Validation Strategy, Quality Management, SAP Compliance, and Regulatory Consulting within the Life Sciences sector.

Apply Now

Ready to take the next step in your career as a Senior Consultant – Computer System Validation (CSV)?
Join Deloitte India in Bengaluru and contribute to the future of digital compliance and operational excellence in life sciences.

👉 Apply directly on the official Deloitte Careers Page:
Apply Here