Join our dynamic Cyber Strategy & Transformation team in Pune as a Consultant specializing in Computerized System Validation (CSV). You will play a crucial role in ensuring our clients' systems are secure, resilient, and compliant.

Deloitte empowers organizations to proactively defend against cyber threats and safeguard their critical assets. Our approach integrates robust security measures with strategic risk management, enabling clients to innovate confidently.

As a valued member of our Cyber team, you'll foster strong client relationships and deliver exceptional results. This role offers an exciting opportunity to contribute to cutting-edge cyber risk management strategies.

Engage in the validation of software applications and computer systems, including GxP Analysis and Gap Assessments.

Participate in Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC) activities, ensuring software quality and risk management.

Review GAMP Guidelines and ensure compliance with client SDLC methodologies and global leadership reporting.

Understand and apply Computer System Validation principles within complex, regulated environments.

Coordinate incident management and corrective actions for validated systems. Evaluate system changes through change control procedures.

Possess knowledge of 21 CFR Part 11 and EU Annexure 11, with experience in FDA-regulated environments and a strong understanding of cGxP.

Experience with GAMP 5 guidelines, other quality regulations, and quality systems like CMMi or ISO is essential.

Demonstrate expertise in validation and qualification of complex computer systems, including knowledge of cGMP regulations related to CSV.

An educational background including a Bachelor's degree in Computer Science, IT, EC, or E, or an MCA from a recognized university is required.