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