Business Architect

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 environment - 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 15 years full time education Important Notice We have been alerted to the existence of fraudulent messages asking job seekers to set up payment to cover various costs associated with establishing employment at Accenture. No one is ever required to pay for employment at Accenture. If you are contacted by someone asking for payment, please do not respond, and contact us at india.fc.check@accenture.com immediately. Equal Employment Opportunity Statement All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law. Please read Accenture’s Recruiting and Hiring Statement for more information on how we process your data during the Recruiting and Hiring process.