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 workplace 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 setting - 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.
Skilled 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

📌 Business Architect Bengaluru (India)
🏢 Accenture
📍 India