CSV Consultant
CSV ConsultantComputer System Validation, Quality Management System, Acquisitions and MergersYesKeywords - CSV, Computer System Validation, Tools validation, Quality Management System, 21 CFR 820, ISO 13485 , Acquisition and mergersIn addition to validation and regulation experience, the resource should have the following
Experience:
Roles and Responsibilities o Minimum 7 years' Experience in the Validating IT software systems like Quality Management System in Life Sciences industryo Experience in FDA and/or Global regulated environment with good understanding of GxP standards like CFR 820 and Risk based validation.
o Experience in validating Global Risk and Compliance moduleso Provides consultation and counseling on Risk and Compliance module implementation in reference to regulatory qualityo Knowledge of FDA guidance's and industry standards o Experience in writing and executing documentation for all aspects of the validation deliverables (etc.
Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports)o Experience in reviewing system test and user acceptance test scripts, Traceability matrix related to System data Archival processo Hands-on experience in software life-cycle management in System data archival processAbility to provide Validation guidance, timely reviews, and escalations to Project teams Recommended Skills Acceptance Testing Consulting Iso 13485 Mergers And Acquisitions Quality Management Risk Analysis Estimated Salary: $20 to $28 per hour based on qualifications.
Experience:
Roles and Responsibilities o Minimum 7 years' Experience in the Validating IT software systems like Quality Management System in Life Sciences industryo Experience in FDA and/or Global regulated environment with good understanding of GxP standards like CFR 820 and Risk based validation.
o Experience in validating Global Risk and Compliance moduleso Provides consultation and counseling on Risk and Compliance module implementation in reference to regulatory qualityo Knowledge of FDA guidance's and industry standards o Experience in writing and executing documentation for all aspects of the validation deliverables (etc.
Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports)o Experience in reviewing system test and user acceptance test scripts, Traceability matrix related to System data Archival processo Hands-on experience in software life-cycle management in System data archival processAbility to provide Validation guidance, timely reviews, and escalations to Project teams Recommended Skills Acceptance Testing Consulting Iso 13485 Mergers And Acquisitions Quality Management Risk Analysis Estimated Salary: $20 to $28 per hour based on qualifications.
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