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Senior technical lead
Job Description
Senior technical lead
Job Summary
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Location: New Jersey
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Project role: Senior technical lead
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Qualification: B-Tech
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Experience: 7-9 Years
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Skills: Computer System Validation (CSV)
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No. of positions: 3
Job description:
New Billing/ Strategic/ Non- Exclusive
Validation Lead- Computer System Validation CSV
Computer System Validation, SAP ECC/S4 HANA validation
Keywords
CSV, Computer System Validation, AP ECC/S4 HANA validation, Solman/ChaRM Change management,
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.
Disclaimer
HCL is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to secure@hcl.com for investigation.