Join Deloitte's Cyber Team as a Consultant in Pune, specializing in Computerized System Validation (CSV). You will be instrumental in helping organizations prevent cyberattacks and protect their valuable assets. This role focuses on managing cyber risk to enable new opportunities, embedding security into strategy from the outset for effective information and technology risk management.

As a key member of our Cyber strategy team, you'll cultivate strong working relationships with colleagues and clients, consistently aiming to surpass expectations. This position offers the chance to contribute to a secure, vigilant, and resilient approach to cybersecurity.

Engage in the validation of software applications and computer systems, including GxP Analysis, Gap Assessment, and ERES Assessment. Contribute to the Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC), applying various testing methodologies. Uphold Software Quality Assurance and Risk Management principles, review GAMP Guidelines, and ensure project lifecycle phases align with client SDLC methodologies. Report compliance status to global leadership and ensure Computer System Validations are applicable in complex change management environments within a regulatory compliance framework.

Understand and apply knowledge of 21 CFR Part 11 of USFDA and EU Annexure 11. Gain experience in FDA-regulated environments with a solid grasp of cGxP. Conduct assessments for GxP relevance and 21 CFR Part 11 requirements like ERES. Coordinate incident management and related corrective/preventative actions to maintain validated systems. Evaluate system changes via change control procedures and participate in planning and implementing changes. Act as a quality contact and Subject Matter Expert (SME) for CSV and Quality Risk Management, having completed multiple end-to-end validation projects.

Demonstrate experience with regulations such as 21 CFR Part 11 and EU Annexure 11, alongside relevant regulatory exposure. Possess experience with GAMP 5 guidelines and other quality regulations/principles, including GxP exposure. A strong background in Quality Systems like CMMi or ISO is expected, along with a proven track record in validating and qualifying complex computer systems. Display knowledge of GxP environments like cGMP regulations for CSV, including CFR 21 Part 11, EU GMP Annex 11, GAMP standards, Part 820, and other applicable standards.

Educational Qualification: A Bachelor's degree in Computer Science, IT, Electronics, or Electrical Engineering (BE/B.Tech from Tier 1/Tier 2 institutions) or a Master of Computer Applications (MCA) from a recognized university is required. Experience in FDA-regulated environments with a good understanding of cGxP is essential.