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Csv Engineer

Csv Engineer

Genpact

7 - 12 years

0 - 1 Lacs

Noida Hyderabad

Posted:1 month ago| Platform:

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Skills Required

Compliance Csv SME Computer System Validation Cfr

Work Mode

Work from Office

Job Type

Full Time

Job Description

nviting 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-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
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

Looking for Immediate to 45 days joiners.

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