Computer Systems Validation ConsultantLife Sciences-21 CFR Part 11
iGATE Global Solutions Limited 430 reviews - Foster City, CA

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Job Title Computer Systems Validation Consultant – Life Sciences 21 CFR Part 11 Job Location Foster City CA About the position and responsibilities Job Description Experience with validation of various systems including test script review and approval process is mandatory 710 years experience in Quality Compliance with a Bachelors degree Experience in FDA regulated environment with good understanding of cGxP (cGMP cGDP cGAMP cGLP) standards and Risk based validation Experience in Computer system validation Experience in reviewing system test and user acceptance test scripts Traceability matrix and Design Specs Experience in writing and executing documentation for all aspects of the validation deliverables (etc Requirements Compliancevalidation Plans test protocols Test Summary reports and Compliancevalidation reports Experience in Software Development Lifecycle (SDLC) Experience in QA Methodologies designing reviewing and approving Test Plans systems and UAT test scripts and Test procedures Experience in Change Control Experience on various FDA standards (21 CFR Part 11 210 211 820) Experience is creation of SOPs Knowledge of FDA guidance’s and industry standards (ie GAMP) Hands on experience in HP Quality Center and QTP Strong verbal and written communication skills Able to work as a team player lead a team or accomplish tasks without supervision Ability to work with remote teams and support several changesprojects simultaneously Flexibility to work with an onshoreoffshore model Participate in the development of strategic compliance deliverables to support applicable regulations and internal policies and to ensure systems to be developed adhere to corporate SDLC methodology Drive understanding and adoption of Quality and Compliance standards Ensure Quality Compliance requirements are considered in any initiative or major change request Ensure the compliance deliverables are updated and kept current with all applicable changes Work with IT and business teams within HCSCLS to drivemaintaincreate Quality program Align development methodology with Compliance plans policies and procedures Effectively manage ongoing change control process (interface to IT support impact analysis release mgt data changes testing etc) Build strong relationships with franchise quality business owners Interested candidates please send resume in Word format to Deepakrawatigatecom mailtoDeepakrawatigatecom Please refer job title when responding to this ad iGATE is an Equal Opportunity Employer Please visit httpwwwigatecom httpwwwigatecom to know more about our Company Computer Systems Validation Consultant Life Sciences - 21 CFR Part 11
About this company
430 reviews
iGATE Corporation (iGATE) is a provider of information technology (IT) and IT-enabled operations offshore outsourcing services to large and...