CSV Engineer - Somerville, United States - Smart Bot Systems

Description

Job Description

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Role: CSV Engineer

Location: Raritan, NJ (Hybrid)

Type: Contract

Job Description:

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.

Thanks and Regards

Puneet Kumar

Smart Bot Systems LLC