CSV Engineer

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Please go through the job description. If you are fine please share your updated resume.

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 riskmanagement 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 riskbased 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