Join our dynamic Cyber CST team as a Consultant, focusing on Computerized System Validation (CSV) in Pune. We help organizations strengthen their defenses against cyberattacks and build resilience. You will be instrumental in managing cyber risk to unlock new opportunities, embedding security from the outset of strategy development.

As a key member of our Cyber strategy practice, your role involves fostering strong relationships with teams and clients, consistently aiming to surpass expectations. This position offers a unique chance to contribute to cutting-edge cybersecurity solutions.

Engage in the validation of software applications and computer systems, including GxP analysis, gap assessments, and ERES assessments. Contribute to Software Development Life Cycle (SDLC), Software Testing Life Cycle (STLC), and various testing methodologies. Ensure compliance with GAMP guidelines and clients' SDLC, reporting compliance status to global leadership. Understand and apply Computer System Validations within complex change management and regulatory frameworks, with knowledge of 21 CFR Part 11 and EU Annexure 11.

Coordinate incident management and related corrective actions. Evaluate system changes through change control procedures and support maintenance to uphold validated states. Act as a primary Subject Matter Expert (SME) for CSV and Quality Risk Management, bringing a proven track record in validating complex systems within GxP environments.

Educational qualification includes any graduate BE/B.Tech (Tier 1/Tier 2) in CS/IT/EC/E, or MCA from a recognized university. Experience with FDA-regulated environments and cGxP is essential, including assessments for GxP relevance and 21 CFR Part 11 compliance. Familiarity with GAMP 5, CMMi, or ISO quality systems is required.

Demonstrable knowledge of GxP environments, cGMP regulations related to CSV, CFR 21 Part 11, EU GMP Annex 11, and GAMP standards is crucial. You should have successfully completed multiple end-to-end computer validation projects and possess a strong background in quality systems. The ideal candidate will have a proven track record in the validation and qualification of complex computer systems.