Join our Cyber Strategy & Transformation team in Pune as an Assistant Manager, specializing in Computerized System Validation (CSV). You will contribute to Deloitte's mission of protecting organizations from cyber threats and managing cyber risk effectively. This role involves building strong client relationships and exceeding expectations within a dynamic cybersecurity environment.

Engage in the validation of software applications and computer systems, conducting GxP analysis, gap assessments, and ERES assessments. You will oversee Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC) processes, manage software quality assurance and risk, and review GAMP guidelines. Ensure compliance with client SDLC methodologies and report compliance status. Understand and apply Computer System Validation principles in regulatory frameworks, adhering to 21 CFR Part 11 and EU Annexure 11.

Coordinate incident management and corrective actions. Evaluate system changes through change control procedures and support system administration. Act as a Subject Matter Expert (SME) for CSV and Quality Risk Management, ensuring validated systems are maintained. You will also be responsible for completing end-to-end validation projects and providing input into quality systems such as CMMi or ISO.

We are seeking a professional with experience in FDA-regulated environments and a solid understanding of cGxP. Experience with 21 CFR Part 11 and EU Annexure 11, along with GAMP 5 and other quality regulations, is essential. A strong background in quality systems like CMMi or ISO, and a proven ability to validate complex computer systems, are required.

Demonstrable knowledge of GxP environments, including cGMP regulations related to CSV, CFR 21 Part 11, EU GMP Annex 11, and GAMP standards, is crucial. Educational qualification includes any Graduate BE/B.Tech (Tier 1/2) in CS/IT/EC/E, or MCA from a recognized university.