Principal Consultant – CSV Analyst

4 weeks ago

Noida, India Genpact Full time

Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose – the relentless pursuit of a world that works better for people – we serve and transform leading enterprises, including the Fortune Global 500, with our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI.

Inviting applications for the role of Principal Consultant – CSV Analyst

In this role, CSV Analyst will prepare and execute test documentation for computerized systems and provide support in the troubleshooting of issues during test execution.

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-basedmethodology

• 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 

• Knowledge of Software validation process and testing methodologies, preferably in a highly regulated environment (medical, aerospace or equivalent).

• Familiarity with the processes and legal requirements for pharmaceutical or medical device industry (cGMP's, 21CFR part11, GAMP) would be a plus.

• Critical thinker and problem-solving skills 

• Team player 

• Good level in English 

• Great interpersonal and communication skills

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