Project Role : Business Architect

Project Role Description : Identify opportunities to deliver tangible business value by assessing the current state, capturing high-level requirements, and defining business solutions. Translate business needs into technology-enabled solutions and operating models. Support transformation by developing business cases and guiding implementation of key initiatives.

Must have skills : Computer System Validation (CSV)

Good to have skills : NA

Minimum 18 Year(s) Of Experience Is Required

Educational Qualification : 15 years full time education

Key Responsibilities a: Pharma Regulatory Compliance and CSV/CSA b: End-to-End CSV in GxP environment with deep experience in validation life cycle and V-Model c: Good understanding of Pharma Regulatory requirements including CFR Part 11 and GAMP5 guidelines d: Ability to make decisions independently and to resolve issues appropriately to achieve a desired result or impact e. Ability to provide GxP validation strategy for the overall program.





Technical Experience a: Experience with at least one of the below: - Cloud Computing/Qualification - Using AI in the regulated workplace - SAP validation b: Experience with pre-sales and solutioning/estimation c: Agile Methodology and Supplier Assessments d: Experience in facing regulatory/ client audits, conducting internal audits, experience in risk management e. General understanding of current technological trends and its use cases in healthcare domain.

Professional Attributes a: Published thought leadership papers/speaker at external seminars b: Leadership and problem-solving Skills d: Strong analytical, communication skills e: Excellent oral and written communication skills

Educational Qualification

BE or equivalent completed

Additional Information

CSV, Validation, 21 CFR Part 11 and computerized system validation

📌 Business Architect (Bengaluru)
🏢 Accenture in India
📍 Bengaluru