CSV Consultant

4 weeks ago

mumbai, India Deloitte Full time

What impact will you make?

Every day, your work will make an impact that matters, while you thrive in a dynamic culture of inclusion, collaboration and high performance. As the undisputed leader in professional services, Deloitte is where you’ll find unrivaled opportunities to succeed and realize your full potential

The Team

Deloitte helps organizations prevent cyberattacks and protect valuable assets. We believe in being secure, vigilant, and resilient—not only by looking at how to prevent and respond to attacks, but at how to manage cyber risk in a way that allows you to unleash new opportunities. Embed cyber risk at the start of strategy development for more effective management of information and technology risks.

Experience : 3+ years

Location : Mumbai

Notice Period : Immediate to 30 days.

Hiring for CSV Professionals:

Knowledge of and experience with regulatory requirements (e.g. GMP, 21 CFR Part 11, 21 CFR Part 820, EU Annex 11 etc..)
Participate as a Validation Subject Matter Expert to support the development of business requirements documentation, technical designs, test strategy and plans, etc.
Responsible to set up the validation strategy to ensure agility & speed in delivery
Minimum of 5 years of relevant work experience as a Computer System Validation Professional, including hands-on experience with domain systems (Enterprise Level Application i.e., ERP, MRP, QMS, LIMS, etc.) in support of global business operations
Should be able to defined and execute end to end validation activities for IT projects and system releases/upgrades
Build effective working relationships and collaborate with other domain and enterprise resources to ensure system validation needs are being met.
Should be able to create and review applicable validation deliverables such as GxP Assessment, Validation Plan, URS, FRS, DS, Configuration Specification, IQ , OQ , PQ test plan , test report , Validation Summary Report etc.
Should have experience in performing Data Migration for validated systems.
Exposure to cloud validation , Supplier assessment.
Exposure to Infrastructure Qualification for GxP relevant systems.
Periodic Reviews of the IT Systems including user reviews and maintaining the validated state of the IT System
Support in Internal audit​ and inspections
Participate in project teams and assist in determining project schedules and the appropriate levels of validation.
Perform validation functional testing as required. Track and resolve deviations during qualification activities.
Test Strategy Definition: Creating a comprehensive testing strategy, including test plans and test data plans across all phases of the SDLC.

Interested applicants kindly mail your resumes to pbhujbal@deloitte.com

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