Consultant CSV Analyst

1 week ago

Noida, India Genpact Full time

Job Description Inviting applications for the role of [Consultant-CSV Analyst] In this role, [Provide CSV support to the Quality and Compliance function working closely with Business and IT stakeholders, App and Infra support teams. Create/update CSV deliverables including IQ/OQ, VPP, VSR, Trace Matrices] Responsibilities - Use risk-based approach and critical thinking in implementing validation approach. - Provide CSV support to the Quality and Compliance function working closely with Business and IT stakeholders, App and Infra support teams. - Responsible for supporting the ongoing validation activities across Application landscape - Provides on-going validation management support to plan, prioritize and deliver system enhancements, general releases, hotfixes, as well as product periodic revalidation. - Closely collaborate with Application Managed services Team and Business/IT stakeholders to ensure requirements/specifications are defined in a clear, testable, and compliant format - Effectively work with cross-functional teams (Product Management, Testing, Technical Operations) to ensure the validated state of the system/application is maintained - Ensure requirements are adequately tested following a risk-based approach - Identify and log issues found during validation execution. Work closely with Product and Testing teams to identify and prioritize issues early on and track validation incidents to closure. - Ensure clear traceability against all testing performed - Create/update CSV deliverables including IQ/OQ, VPP, VSR, Trace Matrices. - Independent pre and post-execution review of validation test scripts - Prepare validation summary reports for executed protocols. - Updates of the system inventory to ensure that is maintained at all times. e.g., addition of systems, retirement of systems, periodic review dates, etc. - Management/input of Change Control, CAPA, Deviations. - Ability to act as responder in audits. Qualifications we seek in you Minimum Qualifications - Degree (Bachelors or Masters) in Computer/Electrical/Electronics Engineering or other relevant Field. - Experience in the Pharma industry with hands on experience as Validation analyst role for US/Europe - Knowledge of Agile software development, and software testing methodologies Preferred Qualifications/ Skills - Excellent written and oral communication skills, good decision-making skills, and time management skills. - Experience with cloud-based applications and/or infrastructure compliance - - - - - -

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