Location: Bengaluru
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
- CSV, Validation, 21 CFR Part 11 and computerized system validation
- 15 years full time education
About Accenture
Accenture is a leading global professional services company that helps the world’s leading businesses, governments and other organizations build their digital core, optimize their operations, accelerate revenue growth and enhance citizen services—creating tangible value at speed and scale. We are a talent- and innovation-led company with approximately 791,000 people serving clients in more than 120 countries. Technology is at the core of change today, and we are one of the world’s leaders in helping drive that change, with strong ecosystem relationships.
We combine our strength in technology and leadership in cloud, data and AI with unmatched industry experience, functional expertise and global delivery capability. Our broad range of services, solutions and assets across Strategy & Consulting, Technology, Operations, Industry X and Song, together with our culture of shared success and commitment to creating 360° value, enable us to help our clients reinvent and build trusted, lasting relationships.
We measure our success by the 360° value we create for our clients, each other, our shareholders, partners and communities.
Visit us atwww.accenture.com
Equal Employment Opportunity Statement
Job description provided by Accenture.
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