Assistant Manager – CSV (Computer System Validation) | Deloitte India | Ahmedabad | SAP

Job Description

Summary

Deloitte India is hiring an Assistant Manager – Computer System Validation (CSV) professional in Ahmedabad to support enterprise-level SAP validation and regulatory compliance initiatives. This is a unique opportunity to contribute to cutting-edge life sciences and technology transformation projects while ensuring adherence to GxP, 21 CFR Part 11, EU Annex 11, and related global standards.

If you have hands-on experience in Computer System Validation, SAP CSV, cloud validation, and regulated IT environments, this role offers the platform to grow your career with a global leader in consulting and professional services.

Job Details at a Glance

About the Role

As an Assistant Manager – CSV at Deloitte India, you will play a critical role in ensuring compliance, validation, and quality assurance for GxP-relevant systems and SAP platforms. You’ll collaborate with cross-functional teams to design, validate, and maintain global enterprise applications while managing risk and regulatory requirements.

Key Responsibilities

• Serve as the Validation Subject Matter Expert (SME) for SAP and enterprise IT systems.
• Develop and execute validation strategies that balance compliance and agility.
• Create and review validation deliverables including:
  • GxP Assessment
  • Validation Plan (VP)
  • User & Functional Requirements (URS, FRS)
  • Design Specifications (DS)
  • Installation, Operational, and Performance Qualifications (IQ, OQ, PQ)
  • Test Plans, Reports, and Validation Summary Reports
• Manage end-to-end validation activities for IT projects and releases.
• Ensure data migration integrity and perform infrastructure qualification for validated systems.
• Conduct periodic reviews to maintain the validated state of systems.
• Handle deviations, CAPA, and change requests using structured RCA methods (e.g., 5 Whys).
• Support supplier audits and vendor assessments.
• Contribute to risk assessment and data privacy evaluations for GxP applications.
• Participate in internal audits, regulatory inspections, and cross-functional reviews.

Required Skills and Experience

• 3–5 years of experience in Computer System Validation (CSV) in a regulated industry.
• Strong understanding of GMP, 21 CFR Part 11, 21 CFR Part 820, and EU Annex 11.
• Hands-on experience with SAP, ERP, LIMS, QMS, or MRP systems.
• Proficiency in validation documentation, testing, and compliance reporting.
• Experience with cloud validation, data migration, and supplier qualification.
• Excellent understanding of IT Risk Management and Validation Lifecycle Management.
• Strong written and verbal communication skills.

Preferred Qualifications

• Graduate or postgraduate degree in Science or Engineering (Computer Science, Life Sciences, or related fields).
• Certification in CSV, GAMP 5, or Quality Management Systems preferred.
• Familiarity with Agile methodologies and global quality systems.
• Strong interpersonal skills and stakeholder communication experience.

Personal Attributes

• Excellent communication and presentation abilities.
• Strong analytical thinking and problem-solving skills.
• Ability to work effectively under pressure in a fast-paced environment.
• Self-motivated with strong collaboration and leadership qualities.
• Adaptable and resilient in managing change and ambiguity.

Why Join Deloitte India

At Deloitte, you’ll have the opportunity to:

• Work on high-impact global SAP and CSV projects.
• Grow through continuous learning and mentorship.
• Experience a hybrid work model that promotes flexibility and balance.
• Be part of a collaborative and inclusive environment.
• Build your career with world-class professional development programs.

Your Role as a Leader

As an Assistant Manager – CSV, you’ll be expected to:

• Lead small teams in delivering quality validation deliverables.
• Collaborate with clients and stakeholders to align on compliance goals.
• Demonstrate accountability and strong delivery excellence.
• Embody Deloitte’s core purpose — making an impact that matters.

How You’ll Grow

Deloitte India offers a dynamic growth environment with structured learning opportunities, leadership programs, and exposure to global projects. Whether through Deloitte University, cross-functional collaboration, or upskilling initiatives, you’ll be supported in achieving your full potential.

Apply Now

Ready to elevate your career as an Assistant Manager – Computer System Validation (CSV) with Deloitte India?

👉 Apply Now on Deloitte’s Official Careers Page

Join a global team that’s redefining technology validation and compliance in enterprise systems.