Join Deloitte's Cyber team as an Assistant Manager in Pune, focusing on Computerized System Validation (CSV). This role involves safeguarding valuable assets and embedding cyber risk management into strategic development. You will build and nurture client relationships, aiming to exceed expectations.

As a key member of the Cyber strategy team, you will collaborate closely with colleagues and clients, ensuring seamless project execution and delivering exceptional service.

This position offers a significant opportunity to contribute to a leading cybersecurity practice and develop your career within a dynamic environment.

Engage in the validation of software applications and computer systems, including GxP analysis, gap assessments, and ERES assessments. You will actively participate in the Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC), applying various testing methodologies. Responsibilities include ensuring software quality, managing risks, and reviewing GAMP guidelines.

Your role will involve ensuring compliance with client SDLC methodologies and reporting compliance status to global leadership. You will also be responsible for understanding and applying Computer System Validation principles within complex, regulatory-compliant environments.

Coordinate incident management and implement corrective actions to maintain validated systems. Evaluate system changes through change control procedures and support system administration to preserve validated states. Act as a Subject Matter Expert (SME) for CSV and Quality Risk Management.

We are seeking professionals with experience in GxP environments and a strong understanding of cGxP. Familiarity with regulations such as 21 CFR Part 11 and EU Annexure 11 is essential, alongside knowledge of GAMP 5 guidelines and other relevant quality regulations. A background in quality systems like CMMi or ISO is highly desirable.

Candidates should possess a proven track record in the validation and qualification of complex computer systems. Demonstrable knowledge of GxP environments, including cGMP regulations related to CSV, CFR 21 Part 11, EU GMP Annex 11, and GAMP standards, is required.

Educational qualifications include any Graduate BE/B.Tech (Tier 1/Tier 2) in CS/IT/EC/E, or MCA from a recognized university. This role requires experience in regulatory environments and a solid understanding of validation processes for computerized systems.