Lead Consultant – CSV Analyst
Genpact
5 - 10 years
Noida
Posted: 31/05/2025
Job Description
Responsibilities
Assist with the development of system requirements and specifications to ensure requirements that are testable, and 21 CFR Part 11 requirements are met
Evaluate proposed changes to validated computer systems and recommend level of validation activities required
Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology
Develop CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan
Where applicable, ensure proper level of software documentation from suppliers (detailed software specifications, architecture diagrams, deployment specs), as well as identification of associated unit and deployment testing prior to release
Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans
Execution of validation plans and validation documents
Qualifications we seek in you!
Minimum Qualifications / Skills
-
BE/B Tech
Preferred Qualifications/ Skills
Familiar with writing tests for Web-based software architectures
About Company
Genpact is a global professional services firm that offers a wide range of digital transformation services and solutions. With a presence in over 30 countries, Genpact leverages its deep domain expertise in operations and analytics to help businesses transform their operations, improve efficiency, and enhance customer experience. The company combines digital technology, data science, and operational excellence to deliver business outcomes across various industries, including banking, insurance, manufacturing, and healthcare. Founded in 1997 as a subsidiary of GE, Genpact has grown into an independent, NYSE-listed company with a diverse workforce of over 90,000 employees globally.
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