CSV Engineer

3 weeks ago

Raritan, United States Novozen Healthcare LLC Full time

Role: CSV Engineer

Location: Raritan, NJ


Roles and Responsibilities:

7+ years of CSV experience with exposure in SAP ECC/S4 HANA system validation, Solman/ChaRM change control process, JIRA/XRAY/qTEST tools for validation required.

Working Knowledge of regulations: 21 CFR Part 11 and Annex 11

Understanding of quality risk-management concepts (ICH Q9) and adept in applying Good Manufacturing Practices principles

Experience in systems validation and quality frameworks and risk based quality approach

Perform quality review of relevant validation documentation pre and post execution for accuracy, completeness and ensures compliance with regulatory and client requirements.

Experience in executing change control and document management

Knowledge of GAMP5 and Quality Systems

Experience on decommission, Archiving and Data Integrity (ALOCA+)

Prior experience in using of tools like qtest, Document Management system (EDMS), ServiceNow and JIRA

Experience in computer systems validation, GXP regulatory knowledge with good documentation methods and CSA approaches and risk-based validation required.

Test automation tools and methods, authoring and/or reviewing validation deliverables such as Compliance Plan, Summary Report, Test Protocols, Test Scripts, Requirements and Trace Matrix is required.

Experience working in Agile methodology and tools is required.

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