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
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
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: Robust 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 (India)
🏢 Accenture
📍 India