- Project Role :Business and Integration Architect
- Project Role Description :Work directly with the client gathering requirements to align technology with business strategy and goals and. Experts internally and externally for their deep functional or industry expertise, domain knowledge, or offering expertise.
- Management Level :7
- Work Experience :12-15 years
- Work location :Pune
- Must Have Skills :CSV (Computer System Validations)
- Good To Have Skills :No Technology Specialization
- Job Requirements :
- Key Responsibilities : a: End-to-End CSV in GxP environment with deep experience in validation life cycle and V-Model b: Pharma Regulatory Compliance and CSV c: Good understanding of Pharma Regulatory requirements including CFR Part 11 and GAMP5 guidelines d: Ability to make decisions independently and and to resolve issues appropriately to achieve a desired result or impact
- 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: Experience in facing regulatory/ client audits, conducting internal audits d: Ability to develop and maintain an effective relationship with client and other stake holders
- Professional Attributes : a: Agile Methadology and Supplier Assessments b: Leadership and problem solving Skills c: Strong analytical, communication skills
- Educational Qualification : BE completed
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